0001564590-21-043440.txt : 20210811 0001564590-21-043440.hdr.sgml : 20210811 20210811161605 ACCESSION NUMBER: 0001564590-21-043440 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20210811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210811 DATE AS OF CHANGE: 20210811 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Histogen Inc. CENTRAL INDEX KEY: 0001383701 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 203183915 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36003 FILM NUMBER: 211163602 BUSINESS ADDRESS: STREET 1: 10655 SORRENTO VALLEY ROAD STREET 2: SUITE 200 CITY: San Diego STATE: CA ZIP: 92121 BUSINESS PHONE: (858) 526-3100 MAIL ADDRESS: STREET 1: 10655 SORRENTO VALLEY ROAD STREET 2: SUITE 200 CITY: San Diego STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: Conatus Pharmaceuticals Inc. DATE OF NAME CHANGE: 20140729 FORMER COMPANY: FORMER CONFORMED NAME: Conatus Pharmaceuticals Inc DATE OF NAME CHANGE: 20061214 8-K 1 hsto-8k_20210811.htm 8-K hsto-8k_20210811.htm
false 0001383701 0001383701 2021-08-11 2021-08-11

 

 

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, 2021

 

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, 2021, Histogen Inc. (the “Company”) issued a press release announcing its results of operations for the three and six months ended June 30, 2021. 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, 2021

     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, 2021

 

By:

/s/  Richard W. Pascoe

 

 

 

Name: Richard W. Pascoe

 

 

 

Title: President and Chief Executive Officer

 

 

 

2

 EX-99.1 2 hsto-ex991_6.htm EX-99.1 hsto-ex991_6.htm

Exhibit 99.1

 

 

CONTACT:

Susan A. Knudson

Executive Vice President & CFO

Histogen Inc.

ir@histogen.com

 

Histogen Reports Second Quarter 2021 Earnings and Provides Business Update

 

Company to Focus its Regenerative Medicine Technology Platform on Developing Orthopedic Product Candidates

 

Initiated Phase 1/2 Study of HST 003 for Cartilage Regeneration in the Knee

 

HST 004 Selected as Product Candidate for Spinal Disc Repair with IND Enabling Activities Underway

 

Positive Top-Line Study Results from its Phase 1 Study of Emricasan in Mild Symptomatic COVID-19 Patients

 

SAN DIEGO, August 11, 2021 – Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today reported financial results for the second quarter ended June 30, 2021 and provided an update on its clinical pipeline and other corporate developments.

 

“In the second quarter, we charted a more strategic course for our restorative therapeutics pipeline with a focus on orthopedic indications that we believe sit at the crossroads of pre-clinical and clinical proof-of-concept, significant commercial opportunity and unmet medical needs,” said Richard W. Pascoe, President and Chief Executive Officer. “Moreover, we believe that there is a significant value-creating opportunity for emricasan as a COVID-19 therapeutic given the positive safety and efficacy signals we reported in the recently completed Phase 1 study in mild symptomatic patients.  Looking forward, we will concentrate our efforts on achieving meaningful regulatory, pre-clinical and clinical milestones for our pipeline assets in an effort to create long-term value for the benefit of patients, the healthcare community and our shareholders.”

 

Highlights from the Second Quarter Ended June 30, 2021 and Business Updates

 

 

•

Technology and Pipeline Focus – In June 2021, we completed a strategic evaluation of our regenerative medicine platform technology and announced that our pipeline focus will be on what we believe to be high-value orthopedic indications, creating pipeline synergies and maximizing resources in an effort to further drive long-term shareholder value.  Our current orthopedic development programs include HST 003 for cartilage regeneration in the knee and HST 004 for spinal disk repair.  Histogen is also evaluating the potential for additional pipeline opportunities targeting other soft tissues such as the tendon and ligament.

 

 

•

HST 003 – In June 2021, we initiated 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. We anticipate having top-line results from this study in the second quarter of 2022.

 

 

Histogen/Page 2

 

 

 

•

HST 004 – We recently initiated investigational new drug application (IND) enabling activities for HST 004, a CCM solution intended to be administered through an intradiscal injection for spinal disc repair.  Our initial preclinical research has shown that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerate normal matrix and cell tissue structure and restore disc height. HST 004 was also shown to both reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. We anticipate filing an IND for HST 004 in the second quarter of 2022.

 

 

•

Emricasan – In June 2021, we, along with our partner Amerimmune, announced positive results from the Phase 1 study of emricasan in mild symptomatic COVID-19 patients. Emricasan was shown to be safe and well-tolerated during the 14 days of dosing and at the day 45 follow up, as compared to placebo with no reports of serious adverse events.  Patients who completed treatment with emricasan had a complete resolution of the symptoms most commonly associated in mild COVID-19, such as a cough, headache, and fatigue at day 7 and continued through Day 45.  Patients in the placebo arm who completed the study did not experience COVID-19 symptom resolution at any time point out to day 45.  We, along with our partner Amerimmune, are currently evaluating our clinical development plans for the emricasan program and expect to complete our evaluation in the third quarter of 2021.

 

Second Quarter 2021 Financial Highlights

 

Second Quarter Ended June 30, 2021 and 2020

 

License and Service Revenues in the second quarter of 2021 decreased nearly 100% to $5 thousand from $0.1 million in the second quarter of 2020. The decrease is primarily related to the completion of technology transfer obligations of Histogen under the Allergan Agreements. During both periods, $5 thousand of deferred revenue was recognized in relation to the Potential Future Improvements remaining performance obligation currently being amortized over the remaining 9-year patent life.  

 

Cost of Professional Services Revenues for the three months ended June 30, 2021 and 2020 were zero and $0.1 million, respectively.

 

Acquired In-Process Research and Development for the three months ended June 30, 2021 and 2020 were zero and $7.1 million, respectively. Histogen incurred $7.1 million for in-process research and development acquired during the three months ended June 30, 2020 in connection with the merger.

 

Research and Development Expenses for the three months ended June 30, 2021 and 2020 were $2.4 million and $1.4 million, respectively. The net increase of $1.0 million for the three months ended June 30, 2021 as compared to the three months ended June 30, 2020 was primarily due to increases in expanded development costs of our product candidates partially offset by $0.2 million in qualifying expenses in connection with the Department of Defense grant and increases in personnel-related expenses.

 

General and Administrative Expenses for the three months ended June 30, 2021 and 2020 were $1.8 million and $1.6 million, respectively. The $0.2 million increase for the three months ended June 30, 2021 as compared to the three months ended June 30, 2020 was primarily due to increases in personnel-related expenses and insurance fees offset by other expenses, such as legal and accounting fees.

 

Histogen/Page 3

 

 

Cash and Cash Equivalents as of June 30, 2021 were $23.1 million. We believe that Histogen’s existing cash and cash equivalents and cash inflow from operations will be sufficient to meet its anticipated cash needs into the fourth quarter of 2022.

 

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 Histogen’s future operations and its ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to the completion and reporting of top-line data for the 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 clinical program for the treatment of COVID-19; the nature, strategy and focus of Histogen’s business; the sufficiency of Histogen’s cash resources based on anticipated cash needs and its ability to achieve value for its stockholders, specifically given the strategic shift to orthopedic indications; the Amerimmune’s ability to further develop emricasan and achieve value for Histogen’s stockholders; and the development and commercial potential and potential benefits of any of Histogen’s product candidates, such as HST 003 and HST 004. Histogen 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 Histogen’s 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: the uncertainties associated with the clinical development and regulatory approval of Histogen’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials, such as the completion and reporting of top-line data for the 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 Amerimmune’s ability to further develop emricasan for the treatment of COVID-19, including the complexity and length of studies required to commercialize emricasan for COVID-19 and potential delays in the completion of clinical trials; Histogen’s dependence on its collaboration partner, Amerimmune, to carry out the development of emricasan and the potential for delays in the timing of regulatory approval; competition in the orthopedics market, COVID-19 market and other markets in which Histogen and its collaboration partner operate; the potential that earlier clinical trials and studies of Histogen’s product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen’s financial condition and increase its costs and expenses; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; 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 elsewhere, including those risks discussed in Histogen’s 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.

 

#            #            #

 

Histogen/Page 4

 

 

HISTOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

 

 

 

June 30,

2021

 

 

December 31,

2020

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

23,140

 

 

$

6,763

 

Restricted cash

 

 

10

 

 

 

10

 

Accounts receivable, net

 

 

118

 

 

 

144

 

Inventories

 

 

61

 

 

 

300

 

Prepaid and other assets

 

 

1,802

 

 

 

1,183

 

Total current assets

 

 

25,131

 

 

 

8,400

 

Property and equipment, net

 

 

270

 

 

 

271

 

Right-of-use assets

 

 

4,291

 

 

 

4,411

 

Other assets

 

 

1,109

 

 

 

1,931

 

Total assets

 

$

30,801

 

 

$

15,013

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

586

 

 

$

539

 

Accrued liabilities

 

 

1,523

 

 

 

1,880

 

Current portion of lease liabilities

 

 

—

 

 

 

28

 

Payroll protection program loan, current

 

 

—

 

 

 

97

 

Financed insurance premiums, current

 

 

—

 

 

 

193

 

Current portion of deferred revenue

 

 

19

 

 

 

48

 

Total current liabilities

 

 

2,128

 

 

 

2,785

 

Payroll protection program loan, non-current

 

 

—

 

 

 

369

 

Lease liabilities, non-current

 

 

4,587

 

 

 

4,806

 

Non-current portion of deferred revenue

 

 

108

 

 

 

118

 

Other liabilities

 

 

18

 

 

 

22

 

Total liabilities

 

 

6,841

 

 

 

8,100

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

 

 

Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized at

   June 30, 2021 and December 31, 2020; no shares issued and outstanding

   at June 30, 2021 and December 31, 2020

 

 

—

 

 

 

—

 

Common stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2021 and

   December 31, 2020; 41,729,257 and 15,030,757 shares issued and outstanding at

   June 30, 2021 and December 31, 2020, respectively

 

 

4

 

 

 

1

 

Additional paid-in capital

 

 

95,603

 

 

 

70,561

 

Accumulated deficit

 

 

(70,676

)

 

 

(62,702

)

Total Histogen Inc. stockholders’ equity (deficit)

 

 

24,931

 

 

 

7,860

 

Noncontrolling interest

 

 

(971

)

 

 

(947

)

Total equity (deficit)

 

 

23,960

 

 

 

6,913

 

Total liabilities and stockholders’ equity (deficit)

 

$

30,801

 

 

$

15,013

 

 

 

 

Histogen/Page 5

 

 

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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

$

—

 

 

$

—

 

 

$

306

 

 

$

—

 

Grant

 

 

—

 

 

 

—

 

 

 

113

 

 

 

—

 

License

 

 

5

 

 

 

5

 

 

 

17

 

 

 

872

 

Professional services

 

 

—

 

 

 

103

 

 

 

—

 

 

 

214

 

Total revenues

 

 

5

 

 

 

108

 

 

 

436

 

 

 

1,086

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

 

—

 

 

 

—

 

 

 

220

 

 

 

161

 

Cost of professional services revenue

 

 

—

 

 

 

89

 

 

 

—

 

 

 

186

 

Acquired in-process research and development

 

 

—

 

 

 

7,144

 

 

 

—

 

 

 

7,144

 

Research and development

 

 

2,376

 

 

 

1,437

 

 

 

4,528

 

 

 

2,828

 

General and administrative

 

 

1,822

 

 

 

1,588

 

 

 

4,154

 

 

 

2,771

 

Total operating expenses

 

 

4,198

 

 

 

10,258

 

 

 

8,902

 

 

 

13,090

 

Loss from operations

 

 

(4,193

)

 

 

(10,150

)

 

 

(8,466

)

 

 

(12,004

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income (expense), net

 

 

(2

)

 

 

(28

)

 

 

(7

)

 

 

(28

)

Other income

 

 

475

 

 

 

—

 

 

 

475

 

 

 

—

 

Total other income (expense)

 

 

473

 

 

 

(28

)

 

 

468

 

 

 

(28

)

Net loss

 

 

(3,720

)

 

 

(10,178

)

 

 

(7,998

)

 

 

(12,032

)

Net loss attributable to noncontrolling interest

 

 

16

 

 

 

10

 

 

 

24

 

 

 

20

 

Net loss attributable to common stockholders

 

$

(3,704

)

 

$

(10,168

)

 

$

(7,974

)

 

$

(12,012

)

Net loss per share available to common stockholders, basic and

   diluted

 

$

(0.10

)

 

$

(1.52

)

 

$

(0.23

)

 

$

(2.39

)

Weighted-average number of common shares outstanding used to

   compute net loss per share, basic and diluted

 

 

37,196,606

 

 

 

6,710,490

 

 

 

34,399,680

 

 

 

5,026,923

 

 

 

 

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Aug. 11, 2021
Cover [Abstract]  
Document Type 8-K
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Document Period End Date Aug. 11, 2021
Entity Registrant Name Histogen Inc.
Entity Central Index Key 0001383701
Entity Emerging Growth Company false
Entity File Number 001-36003
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 20-3183915
Entity Address, Address Line One 10655 Sorrento Valley Road
Entity Address, Address Line Two Suite 200
Entity Address, City or Town San Diego
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92121
City Area Code (858) 
Local Phone Number 526-3100
Written Communications false
Soliciting Material false
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Title of 12(b) Security Common Stock, $0.0001 par value
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Security Exchange Name NASDAQ
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