Posts

Posted on

IntelGenx Reports Third Quarter 2020 Financial Results

SAINT LAURENT, Quebec, Nov. 12, 2020 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX V:IGX)(OTCQB:IGXT) (the “Company” or “IntelGenx”) today reported financial results for the third quarter ended September 30, 2020. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.


20


20


Thir


d


Quarter Financial


Summary


:

  • Revenue was $510,000, compared to $61,000 in the 2019 third quarter
  • Adjusted EBITDA loss was ($1.2 million), compared to ($2.3 million) in Q3-2019


Recent


Development


s:

  • Issued U.S. Patent 10,828,254 entitled “Oral film formulation for modulating absorption profile,” which covers a novel oral film dosage technology platform for modulating the in vivo absorption profile of a sublingually- or buccally-administered active ingredient.
  • Announced the publication of a study in the peer-reviewed International Journal of Clinical Pharmacy evaluating Montelukast’s effect on neurological aging.
  • Closed a private placement in two tranches, raising a total of $1.8 million principal amount of 8% convertible notes due October 15, 2024.
  • Signed a binding letter of intent (“LOI”) with Heritage Cannabis Holdings Corp. (CSE:CANN; OTCQX:HERTF) (“Heritage”) for the supply of filmstrip products containing CBD for the Canadian and Australian markets.
  • Entered into an amended and restated license agreement, granting Tetra Bio-Pharma (TSX:TBP; OTCQB:TBPMF) (“Tetra”) additional exclusive worldwide rights, including the right to manufacture, IntelGenx’s Adversa® mucoadhesive delivery technology.
  • Expanded its RIZAPORT® commercialization agreement with Exeltis Healthcare S.L. (“Exeltis”) to include the European Union.
  • Entered into a feasibility agreement with ATAI Life Sciences (“ATAI’) for the development of novel formulations of pharmaceutical-grade psychedelics.
  • Amended the exclusivity terms of its November 2018 license, development and supply agreement with Tilray, Inc. to allow for IntelGenx’s co-development and commercialization of CBD products with additional partners.
  • Entered into a feasibility agreement with Cybin Corp. for the development of an orally-dissolving film for the delivery of pharmaceutical-grade psilocybin.

“We began to see the results of our performance improvement program being reflected in our financial results this quarter,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We have also continued to execute on our business development strategy by granting Tetra additional exclusive worldwide rights to our Adversa® technology, and entering into a feasibility agreement and a LOI with ATAI and Heritage, respectively, related to our filmstrip technology. In addition, we added 26 European countries to our existing RIZAPORT® commercialization partnership with Exeltis, and are looking forward to their launch of the product in at least one major market early next year.”


Financial Results:

Total revenues for the three-month period ended September 30, 2020 amounted to $510,000, an increase of $449,000, or 736%, compared to $61,000 for the three-month period ended September 30, 2019. The increase is mainly attributable to a $308,000 and $141,000 increase in licensing agreement and research and development revenues, respectively.

Operating costs and expenses were $1.9 million for the third quarter of 2020, versus $2.6 million for the corresponding three-month period of 2019. The decrease for the three-month period ended September 30, 2020 is mainly attributable to a $691,000 decrease in selling, general and administrative expenses.

For the third quarter of 2020, the Company had an operating loss of $1.4 million, compared to an operating loss of $2.5 million for the comparable period of 2019.

Net comprehensive loss for the three-month period ended September 30, 2020 was $1.6 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $2.9 million, or $0.03 per basic and diluted share, for the comparable period of 2019.

As at September 30, 2020, the Company’s cash and short-term investments totalled $1.5 million, which did not include gross proceeds of $1.8 million raised by the Company in its October 2020 convertible notes offering.


Conference Call Details:

IntelGenx will host a conference call to discuss these 2020 third quarter financial results today, Thursday, November 12, 2020, at 4:30 p.m. ET.

Live Call:  1-800‑459‑5346 (Canada and the United States)
  1-203‑518‑9544 (International)

The call will be also be webcast live and archived for twelve months at www.intelgenx.com.

About
IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm® and VetaFilm™, as well as its transdermal development and manufacturing capabilities, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward Looking Statements:

This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions, including, without limitation, anticipated commencement of commercial production of cannabis-infused VersaFilm® and how long operations can be funded based on current assets. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on IntelGenx’s operations, the demand for its products, global supply chains and economic activity in general. IntelGenx assumes no obligation to update any such forward-looking statements.

Each of the TSX Venture Exchange and OTCQB has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source: IntelGenx Technologies Corp.

For
IntelGenx
:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
[email protected]

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
[email protected]

Posted on

Taysha Gene Therapies Reports Third Quarter 2020 Financial Results and Provides Business Update

Taysha Gene Therapies Reports Third Quarter 2020 Financial Results and Provides Business Update

Successfully raised $96 million in Series B financing and completed $181 million IPO

Established management team with successful track record of developing and commercializing AAV9-based gene therapies for monogenic diseases of the central nervous system

Company on track to initiate a Phase 1/2 clinical trial of TSHA-101 in GM2 gangliosidosis by the end of 2020 and plans to submit four INDs in 2021

DALLAS–(BUSINESS WIRE)–Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today reported its financial results for the third quarter of 2020 and provided a business update.

“Just over a year ago, we founded Taysha in partnership with UT Southwestern with a mission to develop gene therapies to address monogenic diseases of the central nervous system, and to that end we have made significant progress in building a talented team that can advance our broad portfolio,” said RA Session, II, President, Founder and CEO of Taysha. “During the third quarter, we raised over $275 million between our Series B financing and our IPO, providing the capital resources to support our industry-leading pipeline of 18 gene therapy programs. We have also bolstered our GMP manufacturing capabilities to ensure we have the capacity to support our development plans for multiple programs by utilizing the UTSW vector core, our internal Taysha manufacturing facility that is currently in development and our newly announced partnership with Catalent.”

Program Highlights

TSHA-101 for GM2 gangliosidosis – Taysha secured rare pediatric disease designation and orphan drug designation from the U.S. Food and Drug Administration (FDA) for TSHA-101, its bicistronic vector designed to treat GM2 gangliosidosis, also known as Tay-Sachs and Sandhoff disease. Taysha anticipates initiating a Phase 1/2 clinical trial of TSHA-101 in Canada by end of 2020.

TSHA-102 for Rett syndrome –Taysha announced that FDA has granted rare pediatric disease and orphan drug designation for TSHA-102, which is under development for the treatment of Rett syndrome, one of the most common genetic causes of severe intellectual disability. TSHA-102 utilizes the miRARE platform, which is designed to regulate the expression of therapeutic transgenes on a cellular basis. Taysha remains on track to file an Investigational New Drug (IND) application for the program in 2021.

TSHA-118 for CLN1 – Taysha announced the in-licensing of an AAV9-based gene therapy program for the treatment of CLN1. TSHA-118 was originally developed in the academic lab of Steven Gray, Ph.D., Taysha’s Chief Scientific Advisor. CLN1 Batten disease is a rapidly progressive rare lysosomal storage disease with no approved treatments. The company intends to initiate a Phase 1/2 clinical trial of TSHA-118 in 2021 under a currently open IND.

Recent Business Highlights

In October, Taysha announced a partnership with Invitae to support two different screening programs to enable rapid identification of patients with genetic disorders. DETECT Lysosomal Storage Diseases provides genetic testing for lysosomal storage disorders, including GM2 gangliosidosis and CLN1. The Behind the Seizures® program supports the diagnosis of patients with genetic epilepsies.

In November, Taysha announced a development and manufacturing partnership with Catalent to support future preclinical and clinical supply for several of Taysha’s gene therapy programs, including CLN1 and Rett syndrome.

Taysha has also invested in building its internal management team to advance the development of its broad gene therapy pipeline. The company anticipates more than tripling its headcount from its IPO by the end of 2020 across all areas of the organization.

Financial Results

As of September 30, 2020, cash and cash equivalents totaled $279 million, which includes gross proceeds of $181 million from Taysha’s IPO and $96 million from its Series B financing. Taysha was incorporated in September of 2019 and thus has no previous nine-month results for comparison.

Taysha reported R&D expenses for the nine months ended September 30, 2020 of $19.6 million. The $19.6 million was primarily attributable to $10.0 million of expenses recognized pursuant to the Queen’s University Agreement and the Abeona CLN1 Agreement, $4.1 million related to the manufacture of clinical trial material and $3.9 million in other sponsored research agreements for the Company’s various product candidates. Additionally, Taysha incurred regulatory and clinical consulting expenses of $0.8 million and employee compensation and benefits expenses of $0.8 million, which included $0.4 million of non-cash stock-based compensation.

Taysha reported G&A expenses of $5.0 million for the nine months ended September 30, 2020. The $5.0 million was primarily attributable to $2.7 million of compensation and benefits related to new hires, which included $0.9 million of non-cash stock-based compensation, $1.7 million in consulting fees, $0.5 million of legal expenses related to general corporate matters and $0.1 million related to insurance and other administrative expenses.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed and the success of our partnerships with Invitae and Catalent. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which we intend to file shortly hereafter and will be available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

Taysha Gene Therapies

Selected Condensed Consolidated Financial Information

(In thousands, except share and per share data)

(Unaudited)

 

Statements of Operations
 
For the
Three Months Ended
September 30,
2020		 For the
Nine Months Ended
September 30,
2020		 For the
Period from
September 20, 2019
(date of inception)
to
September 30,
2019
 
Operating expenses:
Research and development

$

11,057

 

$

19,633

 

$

–

 

General and administrative

 

3,984

 

 

5,002

 

 

31

 

Total operating expenses

 

15,041

 

 

24,635

 

 

31

 

Loss from operations

 

(15,041

)

 

(24,635

)

 

(31

)

Other expense:
Change in fair value of preferred stock tranche liability

 

–

 

 

(17,030

)

 

–

 

Interest expense

 

(1

)

 

(28

)

 

–

 

Total other expense

 

(1

)

 

(17,058

)

 

–

 

Net loss

$

(15,042

)

$

(41,693

)

$

(31

)
 
Net loss per common share, basic and diluted

$

(1.28

)

$

(3.73

)

$

(0.00

)

Weighted average common shares outstanding, basic and diluted

 

11,733,170

 

 

11,176,429

 

 

8,715,999

 

Balance Sheet
 
September 30,
2020		 December 31,
2019
 
ASSETS
Current assets:
Cash and cash equivalents

$ 278,634

$ –

Prepaid expenses

604

–

Deferred offering costs

–

15

Total current assets

279,238

15

Property and equipment, net

28

–

Total assets

$ 279,266

$ 15
 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable

$ 8,837

$ –

Accrued expenses

2,727

150

Due to related party

60

–

Total current liabilities

11,624

150

Total liabilities

11,624

150

 
 
Stockholders’ equity (deficit)
Preferred stock, $0.00001 par value per share; 10,000,000 shares authorized and no shares issued and outstanding as of September 30, 2020; no shares authorized, issued and outstanding as of December 31, 2019

–

–

Common stock, $0.00001 par value per share; 200,000,000 shares authorized and 37,761,435 issued and outstanding as of September 30, 2020; 10,895,000 shares authorized, 10,894,999 issued and outstanding as of December 31, 2019

–

–

Additional paid-in capital

310,450

980

Accumulated deficit

(42,808)

(1,115)

Total stockholders’equity (deficit)

267,642

(135)

Total liabilities and stockholders’ equity (deficit)

$ 279,266

$ 15

 

Company Contact:

Niren Shah, PharmD, MBA

Taysha Gene Therapies

[email protected]

Media Contact:

Carolyn Hawley

Canale Communications

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Health Infectious Diseases Genetics Research Science Pharmaceutical Biotechnology

MEDIA:

Logo
Logo
Posted on

Applied Molecular Transport Reports Third Quarter 2020 Financial Results and Provides Corporate Update

– Company on track with comprehensive AMT-101 Phase 2 clinical program across multiple indications, including inflammatory bowel diseases and rheumatoid arthritis –

– Announced dosing of first patient in Phase 2 monotherapy trial (LOMBARD) evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severe ulcerative colitis –

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020.

“We continue to make important progress in the development of our differentiated oral biologic drug candidates in a number of indications,” said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. “We recently advanced oral AMT-101 into a Phase 2 monotherapy trial in patients with ulcerative colitis (UC). In addition, we continue the planned expansion of this comprehensive clinical program with two additional Phase 2 trials of AMT-101 in combination with anti-TNFα therapy in biologic-naïve patients with moderate to severe UC and as a monotherapy in patients with pouchitis, both initiating by year-end. We are also looking forward to the initiation of the fourth Phase 2 trial for AMT-101 in combination with anti-TNFα in rheumatoid arthritis patients who are partially responding to anti-TNFα therapy. Furthermore, given the broad potential of our technology platform as an engine for the development of novel oral biologics, we continue to work on expanding our deep pipeline into additional indications and therapeutic areas and look forward to sharing updates on our progress.”

Recent Business Highlights

  • Announced dosing of the first patient in the LOMBARD Phase 2 monotherapy trial evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severe UC
  • Successfully manufactured AMT-101 and AMT-126 clinical biologic drug supply at AMT’s internal GMP manufacturing facility
  • Announced publication of preclinical data demonstrating potential of AMT-101 for inflammatory diseases in The Journal of Immunology (November 2020 issue)

Anticipated Upcoming
Milestones

  • Initiate the remaining Phase 2 trials for oral AMT-101:
    • MARKET clinical trial of oral AMT-101 in combination with anti-TNFα, in biologic-naïve, moderate to severe UC patients by year-end
    • FILLMORE clinical trial of oral AMT-101 for the treatment of pouchitis by year-end
    • CASTRO clinical trial of oral AMT-101 in combination with anti-TNFα for the treatment of rheumatoid arthritis in 1H 2021
    • Anticipate top-line data readouts from the four AMT-101 Phase 2 trials beginning in 2H 2021 and into 1H 2022
  • File IND/CTA for AMT-126, a gastrointestinal (GI)-selective oral fusion of hIL-22, to treat serious diseases associated with intestinal epithelial (IE) barrier defects by year-end

Financial Results for the
Third
Quarter Ended
September
30, 2020

Research and development (R&D) expenses. Total R&D expenses for the third quarter of 2020 were $13.4 million, compared to $6.9 million for the same period in 2019. The increase was primarily due to higher expenses associated with clinical trials, preclinical studies, materials, compensation, and facilities related expenses, offset by a decrease in contract manufacturing due to internal capabilities.

General and administrative (G&A) expenses. Total G&A expenses for the third quarter of 2020 were $3.4 million, compared to $1.0 million for the same period in 2019. The increase was primarily due to an increase in personnel costs and professional fees.

Net loss. Net loss for the third quarter of 2020 was $16.8 million, compared to $7.9 million for the third quarter of 2019.

Cash, cash equivalents
, and investments. As of September 30, 2020, cash, cash equivalents, and investments were $147.3 million.

About Applied Molecular Transport Inc.

Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT’s proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the IE barrier. Active transport is an efficient mechanism that uses the cell’s own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly tablet and capsule forms that are designed to either target local GI tissue or enter systemic circulation to precisely address the relevant biology of a disease.

AMT’s headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements including statements relating to AMT’s plans, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMT’s technology platform, statements regarding AMT’s Phase 2 clinical trials for AMT-101 including the timing of such trials, the timing of the filing of IND/CTA for AMT-126, AMT’s ability to leverage its technology to expand its pipeline, presentations regarding AMT-101’s Phase 1b dataset, and AMT-101 top-line data readouts including the timing of such readouts. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our technology platform to build a pipeline of product candidates; uncertainty of developing biologic therapeutics; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercializing of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; potential delays and disruption resulting from the COVID-19 pandemic; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in AMT’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2020, and AMT’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Applied Molecular Transport Inc.

Condensed Bal
ance Sheets

(unaudited)

(in thousands, except share and per share amounts)

    September 30,     December 31,  
    2020     2019(*)  
Assets                
Current assets:                
Cash and cash equivalents   $ 11,314     $ 12,727  
Short-term investments     135,940       19,676  
Prepaid expenses     1,816       532  
Deferred offering costs     —       366  
Other current assets     79       152  
Total current assets     149,149       33,453  
Property and equipment, net     8,437       4,091  
Long-term investments     —       249  
Restricted cash     108       108  
Other assets     127       632  
Total assets   $ 157,821     $ 38,533  
Liabilities, convertible preferred stock and stockholders’ equity (deficit)                
Current liabilities:                
Accounts payable   $ 2,705     $ 2,666  
Accrued expenses     4,692       1,315  
Deferred rent, current     65       13  
Capital lease obligations, current     229       42  
Total current liabilities     7,691       4,036  
Deferred rent     473       526  
Capital lease obligations     463       58  
Total liabilities     8,627       4,620  
Commitments and contingencies                
Series A convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 5,157,213 shares authorized, issued and outstanding, as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $33,000 as of December 31, 2019     —       32,826  
Series B convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 3,992,919 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $31,025 as of December 31, 2019     —       30,921  
Series C convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 4,816,160 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $41,949 as of December 31, 2019     —       41,868  
Stockholders’ equity (deficit):                
Common stock, $0.0001 par value, 450,000,000 and 32,000,000 shares authorized as of September 30, 2020, and December 31, 2019, respectively; 34,880,411 and 7,360,738 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively     3       1  
Additional paid-in capital     269,437       1,078  
Accumulated other comprehensive income     31       13  
Accumulated deficit     (120,277 )     (72,794 )
Total stockholders’ equity (deficit)     149,194       (71,702 )
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)   $ 157,821     $ 38,533  

(*)    Derived from audited Financial Statements.

Applied Molecular Transport Inc.

Condensed Statements of Opera
tions and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2020     2019     2020     2019  
Operating expenses:                                
Research and development   $ 13,395     $ 6,890     $ 39,185     $ 17,756  
General and administrative     3,428       1,008       8,404       2,510  
Total operating expenses     16,823       7,898       47,589       20,266  
Loss from operations     (16,823 )     (7,898 )     (47,589 )     (20,266 )
Interest income, net     59       36       187       107  
Other expense, net     (29 )     (3 )     (81 )     (15 )
Net loss   $ (16,793 )   $ (7,865 )   $ (47,483 )   $ (20,174 )
Net loss per share, basic and diluted   $ (0.48 )   $ (1.07 )   $ (2.53 )   $ (2.74 )
Weighted-average shares of common stock outstanding, basic and diluted     34,767,308       7,360,738       18,770,153       7,360,738  
Comprehensive loss:                                
Net loss   $ (16,793 )   $ (7,865 )   $ (47,483 )   $ (20,174 )
Other comprehensive income (loss):                                
Unrealized gains on investments     29       3       37       3  
Amounts recognized for net realized gains included in net loss     —       —       (19 )     —  
Total comprehensive loss   $ (16,764 )   $ (7,862 )   $ (47,465 )   $ (20,171 )


Investor Relations Contact:


Andrew Chang
Head, Investor Relations & Corporate Communications
[email protected]


Media Contacts:


Alexandra Santos
Wheelhouse Life Science Advisors
[email protected]

Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected] 

Posted on

Kezar Life Sciences to Present During Upcoming Virtual Investor Conferences

Kezar Life Sciences to Present During Upcoming Virtual Investor Conferences

SOUTH SAN FRANCISCO–(BUSINESS WIRE)–
Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced members of the executive team will present during upcoming virtual investor conferences. The details of the presentations are as follows:

Jefferies Virtual London Healthcare Conference

Wednesday, November 18, 2020, 1:10pm EST (Fireside Chat)

Presenters: John Fowler, Chief Executive Officer; Christopher Kirk, PhD, Chief Scientific Officer, and Noreen R. Henig, MD, Chief Medical Officer

2020 Evercore ISI HealthCONx Conference

Thursday, December 3, 2020, 1:00pm EST (Presentation)

Presenter: John Fowler, Chief Executive Officer

The presentations will be webcast live and may be accessed in the “Investors and News” section of the Company’s website at www.kezarlifesciences.com. Kezar Life Sciences will maintain an archived replay of the webcasts on its website for 90 days after the conference.

About Kezar Life Sciences

Based in South San Francisco, Kezar Life Sciences is combining courage, conviction, and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function and inhibit multiple drivers of disease via a single target. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe and underserved autoimmune diseases. Additionally, KZR-261, the first clinical candidate for the treatment of cancer from the company’s protein secretion program targeting the Sec61 translocon, is undergoing IND-enabling activities.

Celia Economides

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Oncology Health Research Pharmaceutical Science Biotechnology

MEDIA:

Posted on

Ra Medical Systems Reports 2020 Third Quarter Financial Results

Ra Medical Systems Reports 2020 Third Quarter Financial Results

Conference call begins at 4:30 p.m. Eastern time today

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focusing on commercializing excimer laser systems to treat vascular and dermatological diseases, reports financial results for the three and nine months ended September 30, 2020 and provides a business update.

Recent Operational Highlights

  • Twelve subjects enrolled in the Company’s atherectomy pivotal clinical trial, for a total of 13 subjects enrolled to date
  • Positive test results support the path to extend the shelf life of future DABRA catheters
  • Next-generation DABRA catheter projects are advancing on or ahead of schedule with prototypes available for in vitro testing
  • The quality improvement program initiated in late 2019 is substantially complete

“I’m encouraged by the progress we’ve made during the third quarter and in recent weeks, in particular with patient enrollment in our atherectomy pivotal trial and with improvements and enhancements to the DABRA catheter,” said Will McGuire, Ra Medical Systems CEO. “We are executing well on our engineering, clinical and quality initiatives, and I am confident that we will deliver on our milestones.”

Third Quarter Financial Highlights

Net revenue for the third quarter of 2020 was $0.9 million, which consisted of product sales of $0.2 million and service and other revenue of $0.7 million. This compares with net revenue of $1.9 million for the third quarter of 2019, which consisted of product sales of $1.1 million and service and other revenue of $0.8 million.

Net revenue from the vascular segment for the third quarter of 2020 was $0.1 million, compared with $0.2 million for the third quarter of 2019. Net revenue from the dermatology segment was $0.8 million for the third quarter of 2020, compared with $1.7 million for the third quarter of 2019.

Total cost of revenue for the third quarter of 2020 was $1.4 million, compared with $2.4 million for the third quarter of 2019.

Selling, general and administrative expenses for the third quarter of 2020 were $4.9 million, which included $0.8 million in stock-based compensation, compared with $15.9 million for the third quarter of 2019, which included $6.6 million in stock-based compensation. Research and development expenses for the third quarter of 2020 were $2.3 million, compared with $1.2 million for the third quarter of 2019. Research and development expenses for the third quarters of 2020 and 2019 included $0.1 million and $0.3 million of stock-based compensation, respectively.

The net loss for the third quarter of 2020 was $7.8 million, or $0.13 per share, compared with a net loss for the third quarter of 2019 of $17.4 million, or $1.30 per share.

Adjusted EBITDA for the third quarter of 2020 was negative $6.2 million, compared with negative $9.9 million for the third quarter of 2019. Adjusted EBITDA is a non-GAAP measure presented as net loss before depreciation and amortization expense, interest income, interest expense, income taxes and stock-based compensation. For additional information regarding the non-GAAP financial measures discussed in this news release, please see “Non-GAAP Reconciliations” below.

Ra Medical reported cash and cash equivalents of $33.6 million as of September 30, 2020.

Nine Month Financial Highlights

Net revenue for the first nine months of 2020 was $3.2 million, which consisted of product sales of $0.9 million and service and other revenue of $2.3 million. This compares with net revenue of $5.8 million for the first nine months of 2019, which consisted of product sales of $3.3 million and service and other revenue of $2.5 million.

Net revenue from the vascular segment was $0.3 million for the first nine months of 2020, compared with $1.1 million for the first nine months of 2019. Net revenue from the dermatology segment was $2.9 million for the first nine months of 2020, compared with $4.7 million for the first nine months of 2019.

Total cost of revenue for the first nine months of 2020 was $4.2 million, compared with $7.1 million for the first nine months of 2019.

Selling, general and administrative expenses for the first nine months of 2020 were $19.1 million, which included $2.5 million in stock-based compensation, compared with $42.9 million for the first nine months of 2019, which included $19.3 million in stock-based compensation. Research and development expenses for the first nine months of 2020 were $5.6 million, which included $0.3 million in stock-based compensation, compared with $3.7 million for the first nine months of 2019, which included $1.4 million in stock-based compensation.

The net loss for the first nine months of 2020 was $25.6 million, or $0.79 per share, compared with a net loss for the first nine months of 2019 of $47.2 million, or $3.63 per share.

Adjusted EBITDA for the first nine months of 2020 was negative $20.8 million, compared with negative $24.4 million for the first nine months of 2019.

Conference Call and Webcast

Ra Medical will hold a conference call and audio webcast to discuss this announcement and answer questions at 4:30 p.m. Eastern time today. The conference call dial-in numbers are 866-777-2509 for domestic callers and 412-317-5413 for international callers, and the passcode is 10149446. A live webcast of the call will be available on the Investor Relations section of www.ramed.com.

A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing 877-344-7529 for domestic callers, 855-669-9658 for Canadian callers or 412-317-0088 for international callers. Please use the passcode 10149446. A webcast replay will be available on the Investor Relations section of www.ramed.com for 30 days, beginning approximately two hours after the completion of the call.

Non-GAAP Financial Measures

Ra Medical has presented certain financial information in accordance with U.S. GAAP and also on a non-GAAP basis for the three- and nine-month periods ended September 30, 2020 and September 30, 2019. EBITDA and Adjusted EBITDA are performance measures that provide supplemental information management believes is useful to analysts and investors to evaluate Ra Medical’s ongoing results of operations, when considered alongside other GAAP measures. These measures are intended to aid investors in better understanding Ra Medical’s current financial performance and prospects for the future as seen through management. Management uses non-GAAP measures to compare the company’s performance relative to forecasts and strategic plans and to benchmark the company’s performance externally against competitors. Management believes that these non-GAAP financial measures facilitate comparisons with Ra Medical’s historical results and with the results of peer companies who present similar measures (although other companies may define non-GAAP measures differently than we define them, even when similar terms are used to identify such measures). Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the company’s operating results as reported under U.S. GAAP. Ra Medical encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP operating results are presented in the accompanying tables of this release.

Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business. Ra Medical defines EBITDA as our GAAP net loss as adjusted to exclude depreciation and amortization, interest income, interest expense and income tax expense. Ra Medical defines Adjusted EBITDA as our GAAP net loss as adjusted to exclude depreciation and amortization, interest income, interest expense, income tax expense and stock-based compensation.

About Ra Medical Systems

Ra Medical Systems commercializes excimer lasers and catheters for the treatment of vascular and dermatological diseases. In May 2017, the DABRA excimer laser system received FDA 510(k) clearance in the U.S. for crossing chronic total occlusions, or CTOs, in patients with symptomatic infrainguinal lower extremity vascular disease with an intended use for ablating a channel in occlusive peripheral vascular disease. The Pharos excimer laser system is FDA-cleared and is used as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. DABRA and Pharos are both based on Ra Medical’s core excimer laser technology platform and deploy similar mechanisms of action. Ra Medical manufactures DABRA and Pharos excimer lasers and catheters in a 32,000-square-foot facility located in Carlsbad, Calif. The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in controlled environments.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Ra Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Ra Medical’s future expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, statements regarding Ra Medical’s business strategy. Ra Medical’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks associated with acceptance of DABRA and Pharos and procedures performed using such devices by physicians, payors, and other third parties; development and acceptance of new products or product enhancements; clinical and statistical verification of the benefits achieved via the use of Ra Medical’s products; the results from our clinical trials, which may not support intended indications or may require Ra Medical to conduct additional clinical trials or modify ongoing clinical trials; challenges related to commencement, patient enrollment, completion, an analysis of clinical trials; Ra Medical’s ability to manage operating expenses; Ra Medical’s ability to effectively manage inventory; Ra Medical’s ability to recruit and retain management and key personnel; Ra Medical’s need to comply with complex and evolving laws and regulations; intense and increasing competition and consolidation in Ra Medical’s industry; the impact of rapid technological change; costs and adverse results in any ongoing or future legal proceedings; adverse outcome of regulatory inspections; and the other risks and uncertainties described in Ra Medical’s news releases and filings with the Securities and Exchange Commission. Information on these and additional risks, uncertainties, and other information affecting Ra Medical’s business and operating results is contained in Ra Medical’s Annual Report on Form 10-K for the year ended December 31, 2019 and in its other filings with the Securities and Exchange Commission. Additional information will also be set forth in Ra Medical’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 to be filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Ra Medical as of the date hereof, and Ra Medical disclaims any obligation to update any forward-looking statements, except as required by law.

Ra Medical investors and others should note that we announce material information to the public about the company through a variety of means, including our website (www.ramed.com), our investor relations website (https://ir.ramed.com/), press releases, SEC filings and public conference calls in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.

Ra Medical Systems, Inc.

Condensed Balance Sheets

(Unaudited)

(in thousands)

 
September 30,
2020		 December 31,
2019
ASSETS
Current Assets
Cash and cash equivalents

$

33,646

$

14,584

Short-term investments

 

—

 

15,993

Accounts receivable, net

 

475

 

786

Inventories

 

2,592

 

2,777

Prepaid expenses and other current assets

 

466

 

1,860

Total current assets

 

37,179

 

36,000

Property and equipment, net

 

3,581

 

5,050

Operating lease right-of-use-assets

 

2,574

 

2,835

Other non-current assets

 

120

 

196

TOTAL ASSETS

$

43,454

$

44,081

 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable

$

899

$

1,532

Accrued expenses

 

4,591

 

2,642

Current portion of deferred revenue

 

1,729

 

2,029

Current portion of equipment financing

 

306

 

293

Current portion of promissory note

 

168

 

—

Current portion of operating lease liabilities

 

346

 

318

Total current liabilities

 

8,039

 

6,814

Deferred revenue

 

656

 

1,232

Equipment financing

 

34

 

265

Promissory note

 

1,832

 

—

Operating lease liabilities

 

2,355

 

2,620

Total liabilities

 

12,916

 

10,931

Total stockholders’ equity

 

30,538

 

33,150

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

43,454

$

44,081

Ra Medical Systems, Inc.

Condensed Statements of Operations

(Unaudited)

(in thousands, except per share data)
 
Three Months Ended September 30, Nine Months Ended September 30,

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net revenue
Product sales

$

183

 

$

1,078

 

$

923

 

$

3,256

 

Service and other

 

731

 

 

830

 

 

2,265

 

 

2,553

 

Total net revenue

 

914

 

 

1,908

 

 

3,188

 

 

5,809

 

Cost of revenue
Product sales

 

670

 

 

1,518

 

 

2,258

 

 

4,848

 

Service and other

 

748

 

 

907

 

 

1,911

 

 

2,252

 

Total cost of revenue

 

1,418

 

 

2,425

 

 

4,169

 

 

7,100

 

Gross loss

 

(504

)

 

(517

)

 

(981

)

 

(1,291

)

Operating expenses
Selling, general and administrative

 

4,933

 

 

15,889

 

 

19,114

 

 

42,907

 

Research and development

 

2,332

 

 

1,182

 

 

5,580

 

 

3,692

 

Total operating expenses

 

7,265

 

 

17,071

 

 

24,694

 

 

46,599

 

Operating loss

 

(7,769

)

 

(17,588

)

 

(25,675

)

 

(47,890

)

Other income (expense), net

 

(10

)

 

173

 

 

74

 

 

684

 

Loss before income tax expense

 

(7,779

)

 

(17,415

)

 

(25,601

)

 

(47,206

)

Income tax expense

 

—

 

 

3

 

 

—

 

 

8

 

Net loss

$

(7,779

)

$

(17,418

)

$

(25,601

)

$

(47,214

)

Basic and diluted net loss per share

$

(0.13

)

$

(1.30

)

$

(0.79

)

$

(3.63

)

Basic and diluted weighted average common shares outstanding

 

59,638

 

 

13,370

 

 

32,443

 

 

13,023

 

Ra Medical Systems, Inc.

Non-GAAP Reconciliations

(Unaudited)

(in thousands)

 
Three Months Ended September 30, Nine Months Ended September 30,

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Statements of Operations Data:
Net loss

$

(7,779

)

$

(17,418

)

$

(25,601

)

$

(47,214

)

Depreciation and amortization

 

631

 

 

460

 

 

1,845

 

 

1,291

 

Interest income

 

(4

)

 

(245

)

 

(128

)

 

(870

)

Interest expense

 

14

 

 

72

 

 

54

 

 

186

 

Income tax expense

 

—

 

 

3

 

 

—

 

 

8

 

EBITDA

 

(7,138

)

 

(17,128

)

 

(23,830

)

 

(46,599

)

Stock-based compensation

 

964

 

 

7,277

 

 

3,044

 

 

22,154

 

Adjusted EBITDA

$

(6,174

)

$

(9,851

)

$

(20,786

)

$

(24,445

)

 

At the Company:

Jeffrey Kraws

President, Ra Medical Systems

760-496-9008

[email protected]

Investors:

LHA Investor Relations

Jody Cain

310-691-7100

[email protected]

KEYWORDS: United States North America California New York

INDUSTRY KEYWORDS: Medical Devices Health Diabetes Research Science Cardiology

MEDIA:

Logo
Logo
Posted on

Retrophin Completes Acquisition of Orphan Technologies

Addition of OT-58 strengthens pipeline of potential first-in-class therapies targeting rare diseases

SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — Retrophin, Inc. (NASDAQ: RTRX) today announced the completion of its previously announced acquisition of Orphan Technologies Limited, a privately held, clinical-stage biopharmaceutical company focused on the development of product candidate OT-58 for the treatment of classical homocystinuria (HCU). OT-58 is a novel investigational human enzyme replacement therapy being evaluated in Phase 1/2 development for the treatment of classical HCU, a rare metabolic disorder characterized by elevated levels of plasma homocysteine that can lead to life-threatening thrombotic events such as stroke and heart attacks, ophthalmologic and skeletal complications, as well as developmental delay.

“We are excited to begin working with the HCU community to develop a deeper understanding of how we can continue to integrate their perspectives into the development of OT-58, and help address their unmet needs,” said Eric Dube, Ph.D., chief executive officer of Retrophin. “We look forward to building upon the promising potential of OT-58 with the goal of developing and ultimately delivering the first disease modifying therapy for people living with HCU.”

Under the terms of the agreement, Retrophin made an upfront payment of $90 million in cash at closing of the transaction. Orphan Technologies shareholders will remain eligible to receive up to $427 million in additional cash payments contingent upon the achievement of key milestones in the development and commercialization of OT-58. Retrophin will also pay a tiered mid-single digit royalty on future net sales of OT-58 in the US and Europe, and potentially make a milestone payment in the event a rare pediatric disease priority review voucher is granted.

Barclays acted as financial advisor, and Cooley LLP acted as legal counsel to Retrophin. Cantor Fitzgerald & Co. acted as financial advisor, and Hogan Lovells US LLP acted as legal counsel to Orphan Technologies.

About
Classical Homocystinuria

Classical homocystinuria (HCU) is a rare genetic metabolic disorder caused by a deficiency in the enzyme cystathionine beta synthase (CBS). CBS is a pivotal enzyme that is essential for the management of methionine and cysteine in the body. Classical HCU leads to toxic levels of homocysteine that can result in life-threatening thrombotic events such as stroke and heart attacks, ophthalmologic and skeletal complications, as well as developmental delay. Current treatment options are limited to protein-restricted diet and supplemental use of vitamin B6 and betaine.

About Retrophin

Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company’s approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin’s R&D efforts are supported by revenues from the Company’s commercial products Chenodal®, Cholbam®, Thiola® and Thiola EC®.

Retrophin.com

About 
Orphan Technologies

Orphan Technologies is a clinical-stage biopharmaceutical company focused on the development of OT-58. OT-58 is an investigational human enzyme replacement therapy being evaluated in Phase 1/2 development for the treatment of classical homocystinuria (HCU). HCU is a rare metabolic disorder characterized by elevated levels of plasma homocysteine that can lead to life-threatening thrombotic events such as stroke and heart attacks, ophthalmologic and skeletal complications, as well as developmental delay.

Forward-Looking Statements

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words “may”, “might”, “believes”, “thinks”, “anticipates”, “plans”, “expects”, “intends” or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references related to; the potential impact upon and benefits to Retrophin from the acquisition of Orphan Technologies; the potential for OT-58 to ultimately become the first disease modifying therapy for HCU; and references to the achievement of future potential development and commercialization milestones for the OT-58 program, including, without limitation, the potential future issuance of a rare pediatric disease priority review voucher. Such forward-looking statements are based on current information available to Retrophin and involve inherent risks and uncertainties, including factors that could delay, divert or change any such forward-looking statements, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Retrophin faces risks associated with, but not limited to: Retrophin’s ability to realize the anticipated benefits of the proposed transaction, including the potential developmental and commercial success of the OT-58 product candidate; significant and unknown transaction costs; actual or contingent liabilities; the risk of litigation and/or regulatory actions related to the transaction; other business effects outside of Retrophin’s control, including the effects of industry, market, economic, political or regulatory conditions or the ongoing COVID-19 pandemic; as well as negative impacts that could result from changes in tax and other laws, regulations, rates and policies. In addition, such risks and uncertainties may include those described in Retrophin’s annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission, which are available at Retrophin’s website (www.retrophin.com) under “Investors & Media”. You are cautioned not to place undue reliance on any forward-looking statements as there are important factors that could cause actual results to differ materially from those in any forward-looking statements, many of which are beyond our control. Except to the extent required by law, Retrophin undertakes no obligation to publicly update any forward-looking statement.

Contact:
Chris Cline, CFA
Senior Vice President, Investor Relations & Corporate Communications
888-969-7879
[email protected]

Posted on

Realize the Full Potential of the NextSeq 2000 with the Power of the P3 Reagent Kit

Realize the Full Potential of the NextSeq 2000 with the Power of the P3 Reagent Kit

Now Commercially Available, Both NextSeq 1000 and NextSeq 2000 Sequencers Include Integrated Informatics and Loss-less Compression Technology, Creating an Intuitive User Experience

SAN DIEGO–(BUSINESS WIRE)–
. Illumina, Inc. (NASDAQ: ILMN) is further extending the reach of the NextSeq™ 2000 Sequencing System with the commercial availability of the P3 high-output flow cell. The P3 flow cell offers 1.1 billion reads in a single sequencing run, almost three times more than previously available on Illumina’s mid-throughput NextSeq sequencing portfolio, expanding the range of applications that run on the system.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201112005974/en/

Now commercially available, Illumina's NextSeq 1000 and NextSeq 2000 (shown here) Sequencers include integrated informatics and loss-less compression technology, creating an intuitive user experience. (Photo: Business Wire)

Now commercially available, Illumina’s NextSeq 1000 and NextSeq 2000 (shown here) Sequencers include integrated informatics and loss-less compression technology, creating an intuitive user experience. (Photo: Business Wire)

“The advanced yet affordable P3 flow cell for the NextSeq 2000 gives customers more capacity to increase the depth and breadth of their projects and the ability to stretch their project budgets, yielding deeper insights,” said Susan Tousi, Chief Product Officer of Illumina. “We’re pleased to further instill customer confidence with the highest data quality ever achieved at commercial launch. Together with the on-instrument integration of our award-winning informatics solution and loss-less compression software, customers can extract actionable insights with a seamless user interface.”

“At University of Edinburgh, our genomics work includes single cell RNA sequencing projects which are often limited by cost,” said Lee Murphy, Head of the Genetics Core at the Edinburgh Clinical Research Facility. “With the NextSeq 2000 and P3 kits, we are experiencing higher output enabling more complex, informative studies which increases the value of our offerings to our world class researchers.”

“The NextSeq 2000 has enabled us to bring sequencing in-house that we would otherwise have to outsource,” said Bryan Venters, Director of Genomic Technologies at EpiCypher, an epigenetic technology company located in North Carolina. “This is critical because it gives us control over our development pipeline. With the release of the P3 cartridge, it will enable higher throughput sequencing and faster turnaround times.”

The P3 flow cell is available in four configurations, including 100-, 200- and 300-cycles, delivering 110 Gb, 220 Gb, and 330 Gb per run, respectively. In response to customer feedback, Illumina is also launching a 50-cycle kit, targeting infectious disease, small RNA, and spatial transcriptomics applications. Additionally, at the outset of 2021, the NextSeq1000 and NextSeq 2000 platforms will come with a tool designed to allow easy recycling of >60% of the reagent cartridge used in each sequencing run.

Illumina also announced the commercial availability of the NextSeq 1000, with an even more accessible price point for sequencing up to 400 million reads per run. Like the NextSeq 2000, the NextSeq 1000 offers onboard informatics for rapid secondary analysis and cloud-based, loss-less compression technology – the first of its kind to offer genomic compression technology built-in. The systems were designed with customers in mind, offering not only a clearer path to deep, actionable insights, but also our most intuitive user experience yet.

“Both the NextSeq 1000 and NextSeq 2000 are designed to simplify workflows and empower labs of any size with the economy of scale to sequence more, more frequently,” said Mark Van Oene, Chief Commercial Officer of Illumina. “With lower run costs, we’re empowering our customers to more freely pursue their research ideas and drive genomics forward.”

The NextSeq 1000 and NextSeq 2000, as well as the P2 and P3 flow cells, are now shipping.

To learn more, visit our website.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and uncertainties, including the expectation for lower costs related to the storing and managing of genomic data costs. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing and launching new products and services; (ii) our ability to deploy new products, services, and applications, and to expand the markets for our technology platforms; and (iii) the acceptance by customers of our newly launched products, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.

Media:

Karen Birmingham, PhD

646-355-2111

[email protected]

Investors:

Juliet Cunningham

858-882-2171

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Technology Other Technology Genetics Research Science

MEDIA:

Logo
Logo
Photo
Photo
Now commercially available, Illumina’s NextSeq 1000 and NextSeq 2000 (shown here) Sequencers include integrated informatics and loss-less compression technology, creating an intuitive user experience. (Photo: Business Wire)
Posted on

NCR to Present at Upcoming Investor Conferences

NCR to Present at Upcoming Investor Conferences

ATLANTA–(BUSINESS WIRE)–
NCR Corporation (NYSE: NCR), a global enterprise technology provider for the banking, retail and hospitality industries, today announced that President and Chief Executive Officer Michael D. Hayford will present to investors at the RBC Capital Markets Technology, Internet, Media and Telecommunications Virtual Conference on Nov. 17, 2020 at 1:20 p.m. Eastern Time.

Chief Financial Officer Tim Oliver will present to investors at the Bank of America Leveraged Finance Virtual Conference on Nov. 30, 2020, at 8:15 a.m. Eastern Time.

Additionally, Tim Oliver will present to investors at the Wells Fargo Securities Virtual TMT Summit on Dec. 1, 2020 at 1:20 p.m. Eastern Time.

A live webcast and replay of the sessions will be available in the Investor Relations section of NCR.com (investor.ncr.com) for 90 days following the sessions.

About NCR Corporation

NCR Corporation (NYSE: NCR) is a leading software- and services-led enterprise provider in the financial, retail and hospitality industries. NCR is headquartered in Atlanta, Ga., with 36,000 employees and does business in 180 countries. NCR is a trademark of NCR Corporation in the United States and other countries.

Web site: www.ncr.com

Twitter: @NCRCorporation

Facebook: www.facebook.com/ncrcorp

LinkedIn: www.linkedin.com/company/ncr-corporation

YouTube: www.youtube.com/user/ncrcorporation

Investor Contact

Michael Nelson

NCR Corporation

678-808-6995

[email protected]

Media Contact

Scott Sykes

NCR Corporation

212-589-8428

[email protected]

KEYWORDS: Georgia United States North America

INDUSTRY KEYWORDS: Technology Software

MEDIA:

Logo
Logo
Posted on

Agile Therapeutics Reports Third Quarter 2020 Financial Results

Commercial Launch of Twirla® Expected by Year-End 2020

$71.9 Million in Cash, Cash Equivalents, and Marketable Securities as of September 30, 2020

Management to Host Conference Call today at 4:30 PM ET

PRINCETON, N.J., Nov. 12, 2020 (GLOBE NEWSWIRE) — Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today reported financial results for the three and nine months ended September 30, 2020 and provided a corporate update.

“With our commercial launch of Twirla expected by the end of the year, we remain on track to deliver on our plan. The final validation of our commercial manufacturing process continues to progress as all three of our batches are expected to be released for commercial use in December 2020. By taking steps to build out an experienced sales force, secure major wholesaler agreements and increase market access for Twirla, we believe we are well-prepared to hit the ground running. Having our first FDA-approved product nearing launch marks an exciting time for Agile and we look forward to bringing to the market another choice for women to help fulfill their contraceptive needs,” said Al Altomari, Chairman and Chief Executive Officer of Agile.

Third Quarter 2020 and Other Recent Corporate Developments:

Twirla Commercialization Update

  • The Company intends to begin shipping product to wholesalers by year-end 2020.
     
  • Agile remains on track to finalize the validation of its commercial manufacturing process of Twirla.
    •  All three validation batches are expected to be released for commercial use in December 2020.
     
  • The Company continued to build its distribution network by entering into an agreement with a third major U.S. wholesaler.
     
  • The Company continues to build awareness among prescribers and health care providers to gain market access for Twirla.
    •  Product sampling expected to begin at launch.
     
  • Through Syneos Selling Solutions, the Company’s contract sales force partner, Agile completed the hiring of an initial sales team of 73 persons.
    •  The sales force initiated discussions with healthcare providers after it was fully deployed in mid-October.

Strengthened Executive Leadership Team

  • In August 2020, the Company appointed Paul Korner, MD, MBA, as Chief Medical Officer. Dr. Korner is a board-certified obstetrician and gynecologist with more than 20 years of pharmaceutical and biotech industry experience, including significant experience within women’s healthcare.

Launched I’m So Done – A National Unbranded Campaign

  • In September 2020, the Company launched I’m So Done, an education and empowerment platform that encourages women to think about their current contraceptive method and decision-making journey.

Financial Guidance

  • The Company narrowed its operating expense guidance for the full year 2020 to be in the range of $52 million to $54 million, with general and administrative expenses accounting for approximately 70% of the spending as it builds out its commercial infrastructure. The Company’s operating expenses guidance includes $2.7 million to $3 million of non-cash stock compensation expense.  The Company expects its gross revenue in the fourth quarter of 2020, reflecting expectations of initial stocking of Twirla by wholesalers, to be approximately $1 million.
     
  • Based on the Company’s current business plan and pending launch of Twirla, the Company believes that its cash, cash equivalents and marketable securities as of September 30, 2020 will be sufficient to meet its projected operating requirements through the end of 2021.  If the COVID-19 pandemic or other factors impact the Company’s current business plans or its ability to generate revenue from the launch of Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations.

Third Quarter Financial Results

  • Cash, cash equivalents and marketable securities
    :  As of September 30, 2020, Agile had $71.9 million of cash, cash equivalents and marketable securities compared to $34.5 million of cash and cash equivalents as of December 31, 2019.
     
  • Research and development (R&D) expenses:  R&D expenses were $3.7 million for the quarter ended September 30, 2020, compared to $2.4 million for the comparable period in 2019. The increase in R&D expenses was primarily due to costs to conduct validation work for commercial manufacturing of Twirla by Corium, the Company’s contract manufacturer. 
     
  • General and administrative (G&A) expenses:  G&A expenses were $11.0 million for the quarter ended September 30, 2020, compared to $2.1 million for the comparable period in 2019.  The increase in G&A expenses was primarily due to higher costs associated with the Company’s pre-commercialization activities for Twirla, such as brand building, advocacy, market research and consulting.  The increase in G&A expenses was also attributable to activities related to building out the commercial organization and included higher salaries and higher professional fees related to recruiting fees and consultants, and an increase in stock compensation expense.
     
  • Net loss:  Net loss was $15.5 million, or $0.18 per share, for the quarter ended September 30, 2020, compared to a net loss of $4.4 million, or $0.08 per share, for the comparable period in 2019.
     
  • Shares Outstanding:  As of September 30, 2020, Agile had 87,434,604 shares of common stock outstanding.

Conference Call and Webcast
Agile Therapeutics will host a conference call and webcast to discuss financial results for the third quarter ended September 30, 2020 today at 4:30pm ET. Investors interested in listening to the conference call may do so by dialing (877) 407-2991 for domestic callers or (201) 389-0925 for international callers. A live webcast will be available in the Events and Presentations section of the Investor Relations page at https://ir.agiletherapeutics.com/events-and-presentations/, or by clicking here.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events and Presentations section of the Company’s website.

About Twirla®
Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated for use as a method of contraception by women of reproductive potential with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate to prevent pregnancy. Healthcare providers (HCPs) are encouraged to consider Twirla’s reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before prescribing.  Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.

About Agile Therapeutics, Inc.

Agile Therapeutics is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women.  Our product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method.  Our initial product, Twirla®, (levonorgestrel and ethinyl estradiol) transdermal system is a non-daily prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company website at www.agiletherapeutics.com. The Company may occasionally disseminate material, nonpublic information on the Company’s website.

Forward-Looking Statement

Certain information contained in this press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We may in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding the status and timing of the validation of our commercial manufacturing process, market availability of Twirla, our projected cash position, our projected fiscal year 2020 operating expenses and gross and net revenue and the expected timing and structure of our commercialization plan for Twirla.  Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to our ability to maintain regulatory approval of Twirla, our ability along with our third-party manufacturer, Corium, to complete successfully the scale-up of the commercial manufacturing process for Twirla, the performance and financial condition of Corium or any of its suppliers, the ability of Corium to produce commercial supply in quantities and quality sufficient to satisfy market demand for Twirla, our ability to successfully commercialize Twirla, the successful development of our sales and marketing capabilities, the accuracy of our estimates of the potential market for Twirla, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and focus, the effects of the COVID-19 pandemic on our operations and the operations of third parties we rely upon as well as on our potential customer base, and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q.  For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Contact: 
Matt Riley
Head of Investor Relations & Corporate Communications
[email protected]        

Agile Therapeutics, Inc.

Balance Sheets

(Unaudited)

(in thousands, except par value and share data)

           
  September 30,   December 31,
  2020
      2019
Assets          
Current assets:          
Cash and cash equivalents $  24,163     $  34,479  
Marketable securities    47,742        —  
Prepaid expenses    1,414        840  
Total current assets    73,319        35,319  
Property and equipment, net    14,271        14,044  
Right of use asset    31        158  
Other non-current assets    1,791        19  
Total assets $  89,412     $  49,540  
           
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable $  5,016     $  1,819  
Accrued expenses    2,154        1,804  
Lease liability, current portion    34        172  
Total current liabilities    7,204        3,795  
           
Long-term debt    16,078        —  
Total liabilities    23,282        3,795  
Commitments and contingencies          
Stockholders’ equity          
Common stock, $.0001 par value, 150,000,000 shares authorized, 87,434,604 and 69,810,305 issued and outstanding at September 30, 2020 and December 31, 2019, respectively    9        7  
Additional paid-in capital    360,713        306,108  
Accumulated other comprehensive income    11        —  
Accumulated deficit    (294,603 )      (260,370 )
Total stockholders’ equity    66,130        45,745  
Total liabilities and stockholders’ equity $  89,412     $  49,540  

Agile Therapeutics, Inc.

Statements of Operations

(Unaudited)

(in thousands, except per share and share data)

                       
  Three Months Ended   Nine Months Ended
  September 30,    September 30, 
  2020      2019      2020      2019
Operating expenses:                      
Research and development $ 3,663     $ 2,361     $ 10,488     $ 7,021  
General and administrative   10,993       2,138       21,824       5,732  
Total operating expenses   14,656       4,499       32,312       12,753  
Loss from operations   (14,656 )     (4,499 )     (32,312 )     (12,753 )
                       
Other income (expense)                      
Interest income   37       67       284       168  
Interest expense   (905 )     —       (2,205 )     —  
Total other income (expense), net   (868 )     67       (1,921 )     168  
Loss before benefit from income taxes   (15,524 )     (4,432 )     (34,233 )     (12,585 )
Benefit from income taxes   —       —       —       —  
Net loss $ (15,524 )   $ (4,432 )   $ (34,233 )   $ (12,585 )
                       
Net loss per share (basic and diluted) $ (0.18 )   $ (0.08 )   $ (0.41 )   $ (0.28 )
                       
Weighted-average common shares (basic and diluted)   87,350,505       53,609,511       83,754,550       44,957,809  
                       
Comprehensive loss:                      
Net loss $ (15,524 )   $ (4,432 )   $ (34,233 )   $ (12,585 )
Other comprehensive income:                      
   Unrealized gain on marketable securities   1       —       11       —  
Comprehensive loss $ (15,523 )   $ (4,432 )   $ (34,222 )   $ (12,585 )

Posted on

Domo Announces Timing of its Third Quarter Fiscal 2021 Results Conference Call

Domo Announces Timing of its Third Quarter Fiscal 2021 Results Conference Call

SILICON SLOPES, Utah–(BUSINESS WIRE)–Domo (Nasdaq: DOMO), provider of the Business Cloud, today announced that results for its third quarter fiscal 2021 (ended October 31, 2020) will be released on December 3, 2020, after the close of the market. The company will host a conference call at 3:00 p.m. (MT) / 5:00 p.m. (ET) to discuss its financial results with the investment community.

Participants can register for the call in advance by visiting http://www.directeventreg.com/registration/event/4296169. Instructions will be shared on how to join the call after registering. A live webcast of the event will be available on the Domo Investor Relations website at http://www.domo.com/IR.

A replay will be available at (800) 585-8367 or (416) 621-4642 with conference ID #4296169 following the completion of the conference call until 11:59p.m. (ET) December 17, 2020.

About Domo

Domo is the Business Cloud, empowering organizations of all sizes with BI leverage at cloud scale, in record time. With Domo, BI-critical processes that took weeks, months or more can now be done on-the-fly, in minutes or seconds, at unbelievable scale. For more information about how Domo (Nasdaq: DOMO) helps its customers go fast, go big and go bold, visit www.domo.com. You can also follow Domo on Twitter, Facebook and LinkedIn.

Domo Disclosure Channels to Disseminate Information

Domo investors and others should note that we announce material information to the public about our company, products and services, and other issues through a variety of means, including Domo’s website, press releases, SEC filings, blogs and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We intend to use the Domo Facebook page, the Domo LinkedIn page, the Domo blog, the @Domotalk Twitter account and the @JoshJames Twitter account as a means of disclosing information about the Company and its services and for complying with the disclosure obligations under Regulation FD. The information we post through these social media channels may be deemed material. Accordingly, we encourage investors and others to monitor these social media channels in addition to following our press releases, SEC filings and public conference calls and webcasts. The social media channels that we intend to use as a means of disclosing the information described here may be updated from time to time as listed on our investor relations webpage.

Domo, Domo Business Cloud and Domo is the Business Cloud are registered trademarks of Domo, Inc.

Media –

Julie Kehoe

[email protected]

Investors –

Peter Lowry

[email protected]

KEYWORDS: Utah United States North America

INDUSTRY KEYWORDS: Software Technology Data Management

MEDIA:

Logo
Logo