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HSTO - Histogen Inc News Story

$0.793 -0.0  -2.1%

Last Trade - 24/09/21

Sector
Healthcare
Size
Micro Cap
Market Cap £24.2m
Enterprise Value £6.56m
Revenue £1.03m
Position in Universe 6262nd / 7172

Histogen Reports First Quarter 2021 Earnings and Provides Business Update

Thu 13th May, 2021 9:01pm
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Strengthened Balance Sheet with $20.8 Million of Gross Proceeds from Financing
and Warrant Exercises

Initiated Phase 1 Study of Emricasan in Symptomatic COVID-19 Patients with
Top-Line Data Anticipated in the Second Quarter of 2021

Initiation of Phase 1/2 Study of HST-003 for Cartilage Regeneration in the
Knee Expected in the Second Quarter of 2021

Appointment of Industry Leaders Dr. Susan Windham-Bannister and Rochelle
Furhmann to our Board of Directors

SAN DIEGO, May 13, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a
clinical-stage therapeutics 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 first quarter ended March 31, 2021 and provided an
update on its clinical pipeline and other corporate developments.

“We continue to focus on advancing our novel pipeline and are pleased to
have initiated the emricasan study for treatment of mild symptomatic COVID-19
patients and are on track to initiate the HST-003 study for knee cartilage
repair in the second quarter of 2021,” said Richard W. Pascoe, President and
Chief Executive Officer. We also welcomed Dr. Susan Windham-Bannister and
Rochelle Fuhrmann to our Board of Directors. Both Sue and Rochelle bring to
our board relevant industry experience with respective expertise in strategic
growth and financial management, which will serve Histogen well. Looking
forward, we will continue to focus on the initiation and execution of the
HST-003 study, delivering top-line results of the emricasan COVID-19 trial,
and completing our evaluation of the clinical development plans for the HST
001 program.”

Highlights from the First Quarter Ended March 31, 2021 and Business Updates
* HST-001 – In February 2021, we announced the final results from the week
26 assessments of our study of HST-001 for the treatment of androgenic
alopecia in men. These results supported that HST-001 was shown to be safe and
well tolerated as compared to placebo with no reports of serious adverse
events but did not achieve statistical significance at week 26 as compared to
placebo. Additional observations at week 26 included that 84% of patients
treated with HST-001, as compared to baseline, demonstrated a statistically
significant change in total hairs (terminal and vellus) within the target area
(TAHC) of the vertex as measured by Canfield’s Hairmetrix macrophotography
system. We are currently evaluating our clinical development plans for the
HST-001 program and expect to complete our evaluation in the second quarter of
2021.


* HST-003 – In March 2021, we announced that the U.S. Food and Drug
Administration (“FDA”) confirmed that we can proceed with the initiation
of our planned 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
enrollment to commence in the second quarter of 2021. Patients will be
enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in
Vail, CO, and Walter Reed Medical Center in Bethesda, MD.


* Emricasan – In March 2021, we, in collaboration with our partner
Amerimmune, announced dosing the first patient in the Phase 1 study of
emricasan for the treatment of mild symptomatic COVID-19 patients. The study
is designed to assess safety and tolerability and will also include various
clinical and laboratory measures and patient reported outcomes (PROs) using
the FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects
in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or
Treatment Assessment tool. We, along with our partner Amerimmune, expect
top-line data to be available in the second quarter of 2021.


* Appointed Dr. Susan Windham-Bannister and Rochelle Furhmann to the board of
directors – In March 2021, we continued to strengthen and diversify our
board with the appointment of Dr. Windham-Bannister and Rochelle Fuhrmann. Dr.
Windham-Bannister is an internationally recognized expert in innovation,
market access and market optimization strategies. She has been recognized by
Biosphere as one of the “10 Most Prominent African American Science
Leaders,” the Boston Globe as one of the “10 Most Influential Women in
Biotech,” by Boston Magazine as one of the “50 Most Powerful Women in
Boston” and is the President of the National Board of Directors of the
Association for Women in Science (AWIS). Dr. Windham-Bannister currently
serves as Managing Partner of Biomedical Innovation Advisors LLC, which she
founded with Dr. Harvey Lodish, co-founder of Genzyme, and member of the
Whitehead Institute, MIT. She also serves as the President and CEO of
Biomedical Growth Strategies, LLC. Ms. Fuhrmann currently serves as the Vice
President Audit and Enterprise Risk Management at Becton Dickinson (BD). In
2016, Ms. Fuhrmann helped establish the BD Foundation, and she presently
serves as Treasurer and as a member of its Board of Trustees. She joined BD in
July 2015 as Senior Vice President and Chief Financial Officer, BD Life
Sciences. Prior to joining BD, Rochelle held various positions responsible for
the management of financial functions, including accounting and financial
reporting, investor relations, corporate finance, risk management and
treasury, primarily in the pharmaceutical industry with companies such as
Amneal Pharmaceuticals and Warner Chilcott plc. She previously served as a
member of the Board of Directors of Concordia International Corp. and held the
position of Audit Committee Chairperson for three years.


* Financings – In January 2021, we received $14 million of gross proceeds
from an S-1 offering and as of March 31, 2021, an incremental $6.8 million of
gross proceeds from the exercise of warrants associated with the January 2021
public offering.
First Quarter 2021 Financial Highlights

First Quarter Ended March 31, 2021 and 2020

Product and Service Revenues in the first quarter of 2021, revenue decreased
56% to $0.4 million from $1.0 million in the first quarter of 2020. The
decrease is primarily related to revenue recognized during the first quarter
of 2020 associated with the Allergan License Agreement amendments offset by
first quarter 2021 revenue related to the final supply of cell conditioned
medium (“CCM”) to Allergan under the Allergan License Agreements.

Cost of revenues for the three months ended March 31, 2021 and 2020 were $0.2
million and $0.3 million, respectively. The cost of product revenue during the
first quarter of 2021 is related to the final supply of CCM sold to Allergan
as compared to $0.2 million of scrapped inventory and $0.1 million of costs
associated with professional services during the first quarter of 2020.

Research and development expenses for the three months ended March 31, 2021
and 2020 were $2.2 million and $1.4 million, respectively. The net increase
of $0.8 million for the three months ended March 31, 2021 as compared to the
three months ended March 31, 2020 was primarily due to increases in expanded
development costs of our product candidates partially offset by $0.2 million
in qualifying reimbursable expenses in connection with the Department of
Defense grant and increases in personnel related expenses.

General and administrative expenses for the three months ended March 31, 2021
and 2020 were $2.3 million and $1.2 million, respectively. The $1.1 million
increase for the three months ended March 31, 2021 as compared to the three
months ended March 31, 2020 was primarily due to incremental costs related to
the transition from a private to a public exchange traded entity, such as
legal, accounting and insurance fees and increases in personnel related
expenses.

Cash and cash equivalents as of March 31, 2021 were $21.7 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 through the
second 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 commencement of the planned HST-003 Phase 1/2
clinical trial for regeneration of cartilage in the knee, the completion and
reporting of topline data for the Phase 1 study of emricasan for the treatment
of COVID-19 and the timing of providing guidance on the HST- 001 clinical
program targeting male androgenic alopecia; the nature, strategy and focus of
Histogen’s business; the sufficiency of Histogen’s cash resources and its
ability to achieve value for its stockholders; the sufficiency of
Amerimmune’s cash resources and its ability to complete the Phase 1 study of
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-001 and HST-003, and the Collaborative Development and
Commercialization Agreement with Amerimmune and any other collaboration
agreements. 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
planned HST-003 Phase 1/2 clinical trial for regeneration of cartilage in the
knee and the reporting of guidance on the HST- 001 clinical program targeting
androgenic alopecia in men 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, such as the emricasan Phase 1
study for the treatment of COVID-19; 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 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; and the requirement for
additional capital to continue to advance these product candidates, which may
not be available on favorable terms or at all. 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 INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)

                                                                                                                                                                                                                          March 31, 2021           December 31, 2020        
                                                                                                                                                                                                                          (unaudited)                                       
 Assets                                                                                                                                                                                                                                                                     
 Current assets:                                                                                                                                                                                                                                                            
 Cash and cash equivalents                                                                                                                                                                                                $         21,743         $          6,763         
 Restricted cash                                                                                                                                                                                                                    10                        10            
 Accounts receivable, net                                                                                                                                                                                                           188                       144           
 Inventories                                                                                                                                                                                                                        61                        300           
 Prepaid and other assets                                                                                                                                                                                                           906                       1,183         
 Total current assets                                                                                                                                                                                                               22,908                    8,400         
 Property and equipment, net                                                                                                                                                                                                        248                       271           
 Right-of-use assets                                                                                                                                                                                                                4,491                     4,411         
 Other assets                                                                                                                                                                                                                       1,166                     1,931         
 Total assets                                                                                                                                                                                                             $         28,813         $          15,013        
 Liabilities and Stockholders’ Equity (Deficit)                                                                                                                                                                                                                             
 Current liabilities:                                                                                                                                                                                                                                                       
 Accounts payable                                                                                                                                                                                                         $         496            $          539           
 Accrued liabilities                                                                                                                                                                                                                1,148                     1,880         
 Current portion of lease liabilities                                                                                                                                                                                               157                       28            
 Payroll protection program loan, current                                                                                                                                                                                           156                       97            
 Financed insurance premiums, current                                                                                                                                                                                               —                         193           
 Current portion of deferred revenue                                                                                                                                                                                                19                        48            
 Total current liabilities                                                                                                                                                                                                          1,976                     2,785         
 Payroll protection program loan, non-current                                                                                                                                                                                       310                       369           
 Lease liabilities, non-current                                                                                                                                                                                                     4,763                     4,806         
 Noncurrent portion of deferred revenue                                                                                                                                                                                             113                       118           
 Other liabilities                                                                                                                                                                                                                  20                        22            
 Total liabilities                                                                                                                                                                                                                  7,182                     8,100         
 Commitments and contingencies (Note 10)                                                                                                                                                                                                                                    
 Stockholders’ Equity (Deficit)                                                                                                                                                                                                                                             
 Preferred stock, $0.0001 par value; 10,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued and outstanding at March 31, 2021 and December 31, 2020                                                 —                         —             
 Common stock, $0.0001 par value; 200,000,000 shares authorized at March 31, 2021 and December 31, 2020; 35,744,457 and 15,030,757 shares issued and outstanding at March 30, 2021 and December 31, 2020, respectively              4                         1             
 Additional paid-in capital                                                                                                                                                                                                         89,554                    70,561        
 Accumulated deficit                                                                                                                                                                                                                (66,972   )               (62,702    )  
 Total Histogen Inc. stockholders’ equity (deficit)                                                                                                                                                                                 22,586                    7,860         
 Noncontrolling interest                                                                                                                                                                                                            (955      )               (947       )  
 Total equity (deficit)                                                                                                                                                                                                             21,631                    6,913         
 Total liabilities and stockholders’ equity (deficit)                                                                                                                                                                     $         28,813         $          15,013        





HISTOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)

                                                                                                               Three Months Ended March 31,                           
                                                                                                               2021                              2020                 
                                                                                                               (unaudited)                                            
 Revenues:                                                                                                                                                            
 Product                                                                                                       $       306                       $      —             
 Grant                                                                                                                 113                              —             
 License                                                                                                               12                               867           
 Professional services                                                                                                 —                                111           
 Total revenues                                                                                                        431                              978           
 Operating expenses:                                                                                                                                                  
 Cost of product revenue                                                                                               220                              161           
 Cost of professional services revenue                                                                                 —                                97            
 Research and development                                                                                              2,153                            1,391         
 General and administrative                                                                                            2,331                            1,183         
 Total operating expenses                                                                                              4,704                            2,832         
 Loss from operations                                                                                                  (4,273      )                    (1,854     )  
 Other income (expense):                                                                                                                                              
 Interest income (expense), net                                                                                        (5          )                    —             
 Total other income (expense)                                                                                          (5          )                    —             
 Net loss                                                                                                              (4,278      )                    (1,854     )  
 Net loss attributable to noncontrolling interest                                                                      8                                10            
 Net loss attributable to common stockholders                                                                  $       (4,270      )             $      (1,844     )  
                                                                                                                                                                      
 Net loss per share available to common stockholders, basic and diluted                                        $       (0.14       )             $      (0.55      )  
 Weighted-average number of common shares outstanding used to compute net loss per share, basic and diluted            31,571,676                       3,343,357     



 

CONTACT: 
Susan A. Knudson
Executive Vice President & CFO 
Histogen Inc. 
ir@histogen.com

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