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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): May 12, 2022

 

Akouos, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

001-39343

81-1716654

(State or Other Jurisdiction
of Incorporation)  

(Commission
File Number)

(IRS Employer
Identification No.)

645 Summer Street
Suite 200
Boston, MA

02210

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (857) 410-1818

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 (see General Instruction A.2. below):

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, $0.0001 par value per share

 

AKUS

 

Nasdaq Global Select 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 May 12, 2022, Akouos, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 2022. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 (including Exhibit 99.1 attached hereto) is being furnished and 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 into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as 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 Issued by Akouos, Inc. on May 12, 2022

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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

AKOUOS, INC.

 

 

Date: May 12, 2022

By: 

/s/ Emmanuel Simons

 

 

Name: Emmanuel Simons, Ph.D., M.B.A.

 

 

Title: President and Chief Executive Officer

Exhibit 99.1

Graphic

Akouos Reports First Quarter 2022 Financial Results and Provides Business Highlights

- Continued progress toward planned IND submissions for AK-OTOF in the first half of 2022 and AK-antiVEGF in 2022

- Presenting new nonclinical data at ASGCT supporting the planned clinical development of AK-OTOF and highlighting the potential use of microRNA target sites in AAV vectors for regulated gene expression in the inner ear

- Presented new nonclinical data at ARO demonstrating potential of precision genetic medicine platform to address a broad range of inner ear conditions

-Ended the first quarter with a strong cash position of $209.1 million

BOSTON, May 12, 2022 Akouos, Inc. (Nasdaq: AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reports financial results for the first quarter ended March 31, 2022 and provides business highlights.

“The year is off to a strong start for us as we continue to progress toward planned IND submissions for AK-OTOF and for AK-antiVEGF in 2022. With the AK-OTOF drug product now vialed, and analytical testing and IND filing preparation underway, we look forward to providing updates later this year regarding the AK-OTOF-101 trial,” said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos. “Building on this momentum, we are presenting new, nonclinical data at ASGCT that support the clinical development of AK-OTOF. These upcoming presentations also highlight the breadth of capabilities within our genetic medicine platform and how they may be applied to address a broad range of inner ear conditions, including those of complex etiology. Our world-class team continues to work diligently to realize the full potential of our platform for individuals who live with disabling hearing loss.”

Pipeline and Business Highlights

Continued progress toward IND submissions for preclinical gene therapy programs AK-OTOF and AK-antiVEGF Akouos continued to advance AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss and is on track to submit an investigational new drug (IND) application in the first half of 2022. Additionally, Akouos is on track to submit an IND in 2022 for AK-antiVEGF, a gene therapy intended for the treatment of patients with vestibular schwannoma.
Advancing genetic medicine platform beyond lead programs to build a product candidate pipeline with the potential to address a broad landscape of inner ear conditions Akouos is working to leverage its multimodal genetic medicine capabilities to

address a broad range of inner ear conditions, including those that are monogenic and those of complex etiology. At the Association for Research in Otolaryngology (ARO) 45th Annual Mid-Winter meeting, the Company presented data that demonstrated genetic medicine platform capabilities, such as AAV-mediated RNA interference gene silencing and CRISPR/Cas9 gene editing methods. The Company continues to progress early-stage pipeline programs, including programs for GJB2-mediated hearing loss and hair cell regeneration.
Nonclinical data will be presented at the American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting In May 2022, Akouos plans to present new nonclinical data at the upcoming ASGCT 25th Annual Meeting. These data support the planned clinical development of AK-OTOF and highlight the potential use of microRNA target sites in AAV vectors for regulated gene expression in the inner ear. Coupled with the nonclinical data presented at ARO, these data build upon and support the potential use of the company’s precision genetic medicine platform to address a broad range of inner ear conditions.

First Quarter Financial Results

Cash Position Cash, cash equivalents, and marketable securities were $209.1 million as of March 31, 2022, as compared to $232.5 million as of December 31, 2021.
Research and Development (R&D) Expenses R&D expenses were $20.4 million for the first quarter ended March 31, 2022, compared to $11.3 million for the same period in 2021. The increase was primarily due to increased efforts in IND-enabling studies and increased manufacturing costs for AK-OTOF and the growth in the number of R&D employees and their related activities, as well as the expense allocated to R&D related to Akouos’s leased facilities.
General and Administrative (G&A) Expenses G&A expenses were $6.6 million for the first quarter ended March 31, 2022, compared to $4.9 million for the same period in 2021. The increase was due to growth in the number of G&A employees and other administrative expenses related to operating as a public company, as well as the expense allocated to G&A related to Akouos’s leased facilities.
Net Loss Net loss was $27.0 million, or $0.78 per share, for the first quarter ended March 31, 2022, compared to $16.1 million, or $0.47 per share, for the same period in 2021.

About Akouos

Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking


statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation, plans, and timing of our future clinical trials and our research and development programs, and the timing of our IND submissions for AK-OTOF and AK-antiVEGF. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our limited operating history; uncertainties inherent in the development of product candidates, including the initiation and completion of nonclinical studies and clinical trials; whether results from nonclinical studies will be predictive of results or success of clinical trials; the timing of and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates; our expectations regarding our regulatory strategy; our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents, and marketable securities; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential addressable patient population for our product candidates; our commercialization, marketing, and manufacturing capabilities and strategy; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with our commercial objectives; the impact of government laws and regulations and any changes in such laws and regulations; risks related to competitive programs; the potential that our internal manufacturing capabilities and/or external manufacturing supply may experience delays; the impact of the COVID-19 pandemic on our business, results of operations, and financial condition; our ability to maintain and establish collaborations or obtain additional funding; and other factors discussed in the “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 29, 2022, and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

 


Condensed Consolidated Balance Sheet Data

(Unaudited)

(in thousands)

March 31, 2022

December 31, 2021

Cash, cash equivalents and marketable securities

$

209,098

$

232,452

Total assets

 

255,958

 

278,755

Total liabilities

46,974

45,105

Total stockholders’ equity

208,984

233,650

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

Three Months Ended March 31, 

2022

2021

Operating expenses:

  

    

  

    

Research and development

$

20,388

$

11,258

General and administrative

 

6,646

 

4,890

Total operating expenses

 

27,034

 

16,148

Loss from operations

 

(27,034)

 

(16,148)

Other income (expense):

 

  

 

  

Interest income

 

257

 

509

Other expense, net

 

(206)

 

(447)

Total other income, net

 

51

 

62

Net loss

$

(26,983)

$

(16,086)

Weighted‑average common shares outstanding, basic and diluted

 

34,528,992

 

34,284,419

Net loss per share attributable to common stockholders, basic and diluted

$

(0.78)

$

(0.47)

Contacts

Media:

Katie Engleman, 1AB

katie@1abmedia.com

Investors:

Courtney Turiano, Stern Investor Relations

Courtney.Turiano@sternir.com