hsto-8k_20220811.htm
false 0001383701 0001383701 2022-08-11 2022-08-11

 

 

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): August 11, 2022

 

Histogen Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-36003

20-3183915

(State or other jurisdiction of

incorporation or organization)

(Commission

File Number)

(IRS Employer

Identification No.)

 

 

 

10655 Sorrento Valley Road, Suite 200,

San Diego CA

 

92121

(Address of principal executive offices)

 

(Zip Code)

 

(858) 526-3100

(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:

 

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

HSTO

The Nasdaq Capital 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 August 11, 2022, Histogen Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2022. The full text of such press release is furnished as Exhibit 99.1 to this report.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall expressly be set forth by specific reference in such filing.

 

Item 9.01

Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit Number

 

Exhibits

    99.1

 

Press Release, dated August 11, 2022

     104

 

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

 

 

*            *            *

1

 


 

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.

 

 

 

 

 

Histogen Inc.

 

 

 

 

Date:  August 11, 2022

 

By:

/s/  Susan A. Knudson

 

 

 

Name: Susan A. Knudson

 

 

 

Title: Executive Vice President and Chief Financial Officer

 

 

 

2

hsto-ex991_6.htm

Exhibit 99.1

 

 

CONTACT:

Susan A. Knudson

Executive Vice President & CFO

Histogen Inc.

ir@histogen.com

 

 

Histogen Reports Second Quarter 2022 Financial Results and Provides Business Update

 

Closed $5M Financing in July

 

Regained Compliance with Nasdaq Minimum Bid Price Requirement

 

 

SAN DIEGO, Aug 11, 2022 – Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics for orthopedic indications and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, today reported financial results for the second quarter ended June 30, 2022 and provided an update on its clinical pipeline and other corporate developments.

“We continue to focus on execution of IND enabling activities for HST 004 in spinal disc regeneration, exploration of testing emricasan in animal studies for methicillin resistant staphylococcus aureus infections (“MRSA”) and evaluating our caspase-1 inhibitors that impact the inflammasome pathway,” said Steven J. Mento, Ph.D., Interim President and Chief Executive Officer. “We also initiated a feasibility evaluation of our ongoing HST 003 study for cartilage regeneration in the knee, including implementation of protocol modifications, adding more sites, and other study resources given the continued recruitment challenges stemming from both the study protocol and impact of COVID-19 on the elective surgery environment and expect to complete our evaluation in the fourth quarter of 2022.”

 

Highlights from the Second Quarter 2022 and Business Updates

 

 

HST 003 – Our Phase 1/2 clinical study of HST 003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure is on-going. Despite adding three additional clinical sites in the first quarter of 2022, we continue to experience recruitment challenges due to both the specific nature of the study inclusion criteria and the impact of COVID-19 on the elective surgery environment. We are currently evaluating the overall feasibility of the ongoing HST 003 trial, including implementing protocol modifications, adding more sites, and other study resources.  We expect to complete our feasibility evaluation in the fourth quarter of 2022.

 

 

HST 004 – Our initial preclinical research has shown that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerates normal matrix and cell tissue structure and restores disc height. HST 004 was also shown to reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. We continue to execute on IND enabling activities for HST-004 and anticipate filing IND for HST-004 in the second half of 2023.  

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Emricasan MRSA - We continue to make progress on exploring the feasibility of testing emricasan in animal studies for MRSA.  We expect to complete our feasibility assessment in the third quarter of 2022.

 

 

Regained Compliance with Nasdaq Minimum Bid Listing Requirement - On June 2, 2022, we effected a 1-for-20 reverse stock split of the Company’s issued and outstanding common stock, par value $0.0001 per share. Subsequently, we received written notice from the Listing Qualifications Department of the Nasdaq Stock Market stating that the Company has regained compliance with the Nasdaq minimum bid price listing requirement.

 

 

$5 Million Financing – In July 2022, we closed a $5 million private placement financing.  We anticipate that the net proceeds, in addition to our cash of $12.6M as of June 30, 2022, will support our operations through December 2023.

 

 

Six Months Ended June 30, 2022 Financial Highlights

 

Product, License, and Grant Revenues

For the six months ended June 30, 2022 and 2021, we recognized product revenues of $0 and $0.3 million, respectively. The revenue for the first six months of 2021 was related to the additional supply of cell conditioned medium (CCM) to Allergan. As of March 31, 2021, all obligations of the Company related to the additional supply of CCM to Allergan under the Allergan Agreements have been completed.

For the six months ended June 30, 2022 and 2021, we recognized license revenue of $3.8 million and $17 thousand, respectively. The increase in the current period is due to a one-time payment of $3.8 million received in March 2022 as consideration for execution of the Allergan Letter Agreement.

For the six months ended June 30, 2022 and 2021, we recognized grant revenue of $0 and $0.1 million, respectively. The related revenue is associated with a research and development grant awarded to the Company from the National Science Foundation (NSF). As of March 31, 2021, all work required by the Company under the grant has been completed.

Cost of revenues for the six months ended June 30, 2022 and 2021, we recognized $0 and $0.2 million, respectively, for cost of product sold to Allergan under the Allergan Agreements.

Research and development expenses for the six months ended June 30, 2022 and 2021 were $3.0 million and $4.5 million, respectively. The decrease of $1.5 million was primarily due to decreases in development costs of our clinical and pre-clinical product candidates and personnel related expenses, partially offset by facility rent increases.

General and administrative expenses for the six months ended June 30, 2022 and 2021 were $4.8 million and $4.2 million, respectively. The increase of $0.6 million was primarily due to increases in royalty expenses and legal fees, offset by reductions in personnel related expenses.

Cash and cash equivalents as of June 30, 2022 were $12.6 million which excludes gross proceeds of approximately $5 million from the private placement financing closed in July 2022. Histogen believes that

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its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs through December of 2023.

 

About Histogen Inc.

 

Histogen Inc. is a clinical-stage therapeutics company focused on developing both potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function as well as a pipeline of clinical and preclinical small molecule pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases. Under our

biologics technology platform, our product candidates in development are HST-003, a treatment for joint cartilage repair, and HST-004, a treatment for spinal disc repair. In addition, within our small molecule pipeline, our product candidates include emricasan, CTS-2090 and CTS-2096. Currently, emricasan is being developed jointly with our collaboration partner, Amerimmune, for the treatment of COVID-19, and we are evaluating the use of emricasan for other infectious diseases including the treatment of MRSA. We also have preclinical product candidates, CTS-2090 and CTS-2096, novel, potent, orally bioavailable, and highly selective small molecule inhibitors of caspase-1 designed for the treatment of certain inflammatory diseases. For more information, please visit www.histogen.com.

 

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our future operations and our ability to successfully initiate, enroll and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to the initiation, completion and reporting of top line results for HST-003 Phase 1/2 clinical trial for regeneration of cartilage in the knee, the completion of IND enabling activities and the anticipated filing of the HST-004 IND for spinal disc repair and the timing of providing clinical development guidance on the emricasan and any further evaluation of CTS-2090 and CTS-2096. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: our ability to obtain funding for our operations, including funding necessary to complete further development and any commercialization of our product candidates; our expectations regarding the arbitration and judicial proceedings related to emricasan and the joint development with Amerimmune for COVID-19 and other infectious and inflammatory diseases, including its ability to carry out the development of emricasan and the potential for delays in the timing of regulatory approval and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; our expectations regarding the operation of our product candidates, collaborations and related benefits; our beliefs regarding the success, cost and timing of our product candidate development and collaboration activities and current and future clinical trials and studies; our beliefs regarding the potential markets for our product candidates, collaborations and our collaborators’ ability to serve those markets;  any impact of the COVID-19 pandemic, or responses to the pandemic, on our business, collaborations, clinical trials or personnel;  our beliefs regarding our industry;  our ability to attract and retain key personnel; regulatory developments in the United States and foreign countries, with respect to our product candidates; the expected impact of any arbitration and litigation proceedings on our business, cash resources and the time required by management to address such proceedings; the impact of any arbitration and litigation proceedings on our business and market and other conditions. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and

3


elsewhere, including those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

 

#          #          #

4


HISTOGEN INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

 

 

$

 

 

$

 

 

$

306

 

License revenue

 

 

5

 

 

 

5

 

 

 

3,760

 

 

 

17

 

Grant revenue

 

 

 

 

 

 

 

 

 

 

 

113

 

Total revenue

 

 

5

 

 

 

5

 

 

 

3,760

 

 

 

436

 

Operating expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

 

 

 

 

 

 

 

 

 

 

220

 

Research and development

 

 

1,093

 

 

 

2,376

 

 

 

3,025

 

 

 

4,528

 

General and administrative

 

 

2,306

 

 

 

1,822

 

 

 

4,812

 

 

 

4,154

 

Total operating expense

 

 

3,399

 

 

 

4,198

 

 

 

7,837

 

 

 

8,902

 

Loss from operations

 

 

(3,394

)

 

 

(4,193

)

 

 

(4,077

)

 

 

(8,466

)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

 

 

 

(2

)

 

 

(1

)

 

 

(7

)

Other Income

 

 

 

 

 

475

 

 

 

 

 

 

475

 

Net loss

 

 

(3,394

)

 

 

(3,720

)

 

 

(4,078

)

 

 

(7,998

)

Loss attributable to noncontrolling interest

 

 

6

 

 

 

16

 

 

 

17

 

 

 

24

 

Deemed dividend - accretion of discount and redemption feature of redeemable convertible preferred stock

 

 

(488

)

 

 

 

 

 

(488

)

 

 

 

Net loss available to common stockholders

 

$

(3,876

)

 

$

(3,704

)

 

$

(4,549

)

 

$

(7,974

)

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

 

$

(1.55

)

 

$

(1.99

)

 

$

(1.82

)

 

$

(4.64

)

Weighted-average number of common shares outstanding used to compute net loss per share, basic and diluted

 

 

2,497,450

 

 

 

1,859,770

 

 

 

2,497,450

 

 

 

1,719,925

 

 

5


 

HISTOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

 

 

 

 

 

June 30,

2022

 

 

December 31,

2021

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

12,598

 

 

$

18,685

 

Restricted cash

 

 

400

 

 

 

400

 

Accounts receivable, net

 

 

88

 

 

 

165

 

Prepaid and other current assets

 

 

1,941

 

 

 

2,359

 

Total current assets

 

 

15,027

 

 

 

21,609

 

Property and equipment, net

 

 

510

 

 

 

399

 

Right-of-use asset

 

 

4,816

 

 

 

4,432

 

Other assets

 

 

692

 

 

 

805

 

Total assets

 

$

21,045

 

 

$

27,245

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

534

 

 

$

1,393

 

Accrued liabilities

 

 

372

 

 

 

791

 

Current portion of lease liabilities

 

 

212

 

 

 

127

 

Current portion of deferred revenue

 

 

19

 

 

 

19

 

Total current liabilities

 

 

1,137

 

 

 

2,330

 

Lease liabilities, non-current

 

 

4,504

 

 

 

4,617

 

Noncurrent portion of deferred revenue

 

 

89

 

 

 

98

 

Finance lease liability, non-current

 

 

9

 

 

 

14

 

Total liabilities

 

 

5,739

 

 

 

7,059

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

Stockholders' Equity

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2022 and December 31, 2021; no shares issued and outstanding at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 2,497,450 shares issued and outstanding at June 30, 2022 and December 31, 2021

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

98,037

 

 

 

98,839

 

Accumulated deficit

 

 

(81,713

)

 

 

(77,652

)

Total Histogen Inc. stockholders’ equity

 

 

16,329

 

 

 

21,192

 

Noncontrolling interest

 

 

(1,023

)

 

 

(1,006

)

Total equity

 

 

15,306

 

 

 

20,186

 

Total liabilities and stockholders’ equity

 

$

21,045

 

 

$

27,245

 

 

6