Alpine Immune Sciences to Participate in Fireside Chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference

Alpine Immune Sciences to Participate in Fireside Chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference

SEATTLE–(BUSINESS WIRE)–
Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference.

The fireside chat will be available online during the week of November 23 in the investor relations section of the company’s website at https://ir.alpineimmunesciences.com/events. The virtual conference will be held from December 1-3, 2020.

About Alpine Immune Sciences, Inc.

Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is creating multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

“Secreted Immunomodulatory Proteins”, “SIP”, “Transmembrane Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,” “vIgD” and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

Paul Rickey

Chief Financial Officer

Alpine Immune Sciences, Inc.

206-788-4545

[email protected]

Laurence Watts

Managing Director

Gilmartin Group, LLC.

619-916-7620

[email protected]

KEYWORDS: Washington United States North America

INDUSTRY KEYWORDS: Biotechnology Health Oncology

MEDIA:

Fastly to Present at Upcoming Investor Conferences

Fastly to Present at Upcoming Investor Conferences

SAN FRANCISCO–(BUSINESS WIRE)–Fastly, Inc. (NYSE: FSLY), provider of a global edge cloud platform, announced today that Chief Executive Officer Joshua Bixby and Chief Financial Officer Adriel Lares will participate in fireside chats at the following investor conferences:

  • Needham Virtual Security, Networking, and Communications Conference on Tuesday, November 17, 2020 at 12:00 p.m. PT / 3:00 p.m. ET
  • Credit Suisse 24th Annual Technology Conference on Monday, November 30, 2020 at 9:20 a.m. PT / 12:20 p.m. ET
  • 2020 Wells Fargo TMT Summit on Tuesday, December 1, 2020 at 2:20 p.m. PT / 5:20 p.m. ET

Webcasts of these presentations will be available on Fastly’s Investor Relations website at https://investors.fastly.com.

About Fastly

Fastly helps people stay better connected with the things they love. Fastly’s edge cloud platform enables customers to create great digital experiences quickly, securely, and reliably by processing, serving, and securing our customers’ applications as close to their end-users as possible — at the edge of the internet. Fastly’s platform is designed to take advantage of the modern internet, to be programmable, and to support agile software development with unmatched visibility and minimal latency, empowering developers to innovate with both performance and security. Fastly’s customers include many of the world’s most prominent companies, including Vimeo, Pinterest, The New York Times, and GitHub.

Source: Fastly, Inc.

Investor Contact:

[email protected]

Media Contact:

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Software Mobile/Wireless Networks Professional Services Internet Hardware Data Management Technology Security Other Professional Services Other Technology Consulting Telecommunications

MEDIA:

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Citrix Executives to Present at Upcoming Investor Conferences

Citrix Executives to Present at Upcoming Investor Conferences

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–
Citrix Systems, Inc. (NASDAQ:CTXS) today announced its participation in five upcoming investor conferences:

Event: 2020 RBC Capital Markets Global TIMT Virtual Conference

Date and Time: November 17, 2020 at 8:00 a.m. Eastern

Presenter: PJ Hough, executive vice president and chief product officer

Event: 2020 Wells Fargo TMT Summit

Date and Time: December 2, 2020 at 9:20 a.m. Eastern

Presenter: Arlen Shenkman, executive vice president and chief financial officer

Event: Raymond James 2020 Technology Investors Conference

Date and Time: December 7, 2020 at 12:30 p.m. Eastern

Presenter: Mark Schmitz, executive vice president and chief operating officer

Event: UBS Global TMT Virtual Conference

Date and Time: December 8, 2020 at 12:05 p.m. Eastern

Presenter: PJ Hough, executive vice president and chief product officer

Event: Barclays Global Technology, Media and Telecommunications Conference

Date and Time: December 10, 2020 at 3:00 p.m. Eastern

Presenter: Arlen Shenkman, executive vice president and chief financial officer

A webcast of each presentation will be available live on the investor section of the Citrix website at www.investors.citrix.com. A replay will be available for approximately 30 days.

About Citrix

Citrix (NASDAQ:CTXS) builds the secure, unified digital workspace technology that helps organizations unlock human potential and deliver a consistent workspace experience wherever work needs to get done. With Citrix, users get a seamless work experience and IT has a unified platform to secure, manage, and monitor diverse technologies in complex cloud environments. Learn more at www.citrix.com.

For Citrix Investors

This release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and of Section 21E of the Securities Exchange Act of 1934. These forward-looking statements do not constitute guarantees of future performance. Those statements involve a number of factors that could cause actual results to differ materially, including risks associated with transitions in key personnel and succession, products, their development, integration and distribution, product demand and pipeline, customer acceptance of new products, economic and competitive factors, Citrix’s key strategic relationships, acquisition and related integration risks as well as other risks detailed in Citrix’s filings with the Securities and Exchange Commission. Citrix assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.

Citrix® is a trademark or registered trademark of Citrix Systems, Inc. and/or one or more of its subsidiaries, and may be registered in the U.S. Patent and Trademark Office and in other countries. All other trademarks and registered trademarks are property of their respective owner

For media inquiries, contact:

Karen Master, Citrix Systems, Inc.

(216) 396-4683 or [email protected]

For investor inquiries, contact:

Traci Tsuchiguchi, Citrix Systems, Inc.

(408) 790-8467 or [email protected]

KEYWORDS: Florida United States North America

INDUSTRY KEYWORDS: Data Management Professional Services Technology Software Human Resources

MEDIA:

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QIAGEN Launches NeuMoDx Multiplex Test to Complete Range of SARS-CoV-2 Testing Solutions in Europe and Other Markets

QIAGEN Launches NeuMoDx Multiplex Test to Complete Range of SARS-CoV-2 Testing Solutions in Europe and Other Markets

  • Fast and easy-to-use respiratory PCR test comes onto market as flu season gains pace in Northern Hemisphere
  • CE-IVD marking in Europe granted for NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test, has also been submitted to FDA for Emergency Use Authorization
  • Test adds to QIAGEN’s growing portfolio of PCR testing solutions for COVID-19 testing
  • QIAGEN also expands sample type claim for NeuMoDx™ SARS-CoV-2 test to include saliva from a dedicated collection kit in Europe

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)–
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the European launch of the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageTest that will help healthcare professionals quickly identify and differentiate between patients with common seasonal respiratory infections and COVID-19.

With the Northern Hemisphere in the grip of flu season, this multiplex polymerase chain reaction (PCR) test detects and differentiates influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes. These viruses produce similar respiratory symptoms, making it essential to provide differential diagnosis among them for patient treatment and management decisions, especially in the COVID-19 pandemic.

QIAGEN has launched NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage in the European Union and other markets after CE-IVD registration, and has submitted an Emergency Use Authorization (EUA) request to the FDA.

QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features ­­– like processing capacity, true random access, and continuous loading of samples, reagents and consumables while the system is running – the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage test will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.

In addition, QIAGEN has expanded specimen types that can be used on the existing NeuMoDx™ SARS-CoV-2 test. CE-IVD approval has been obtained for the use of saliva samples collected with the NeuMoDx™ Saliva Collection Kit, which includes a collection vial, stabilization tube and pipette.

Please find the full press release here

###

Investor Relations

John Gilardi

+49 2103 29 11711

Phoebe Loh

+49 2103 29 11457

e-mail: [email protected]

Public Relations

Thomas Theuringer

+49 2103 29 11826

Robert Reitze

+49 2103 29 11676

e-mail: [email protected]

KEYWORDS: Switzerland United States Austria North America Europe Germany Maryland

INDUSTRY KEYWORDS: Health Medical Devices Infectious Diseases Technology Other Technology Research Science

MEDIA:

AGTC Announces Financial Results and Business Update for the Quarter Ended September 30, 2020

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced financial results for the quarter ended September 30, 2020. The Company is also providing an update on its ongoing clinical trials in patients with X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM).

“The updated XLRP data that we reported last week provide evidence that our XLRP product candidate provides durable improvements in visual sensitivity and visual acuity over a wide dose range and has a favorable safety profile,” said Sue Washer, President and CEO of AGTC. “Data publicly reported by our competitors this weekend at the American Academy of Ophthalmology (AAO) Annual Meeting further increase our confidence that we have the industry-leading XLRP program. We are on track to initiate enrollment in the planned Phase 1/2 expansion trial (Skyline) in 4Q 2020 and the Phase 2/3 trial (Vista) in 1Q 2021. Additionally, new data from our ongoing ACHM trials have provided important insights for the potential development of our ACHM product candidates. We are pleased that we met our goal of reporting out data from all three ongoing clinical trials in 4Q 2020 and are now focused on advancing the Skyline and Vista trials for XLRP as rapidly as possible.”

XLRP

On November 11, 2020, the Company reported additional positive data from its Phase 1/2 clinical trial in patients with XLRP that indicated durable improvements observed in visual sensitivity and visual acuity over a wide dose range with a favorable safety profile out to month 12 in two of the dose groups. Based on comparison to publicly released data reported by competitors this weekend at the AAO Annual Meeting, the Company believes it has a best-in-class product that may provide significant benefit to patients with XLRP.

ACHM

Today the Company is reporting 12-month ACHM data in the original three dose groups (low, medium and high), as well as 6- to 9-month data at two higher dose groups (higher and highest groups in the January 2020 data release), and data for 6 pediatric subjects (three in each study; 12-17 years old) at the first of three planned dose levels. While some patients showed improvements in at least one measure of visual function, no consistent sustained improvements were observed based on current assessments within the dose groups tested. However, anecdotal statements and assessments from patient-reported outcome surveys continue to provide the Company with confidence that patients are subjectively experiencing improved vision. Based on the characteristics of ACHM, the Company continues to believe that longer treatment durations and/or focusing on younger patients may be necessary to fully realize the potential of this treatment. To this end, the Company intends to complete the planned enrollment of pediatric patients in the two highest dose groups of the ongoing ACHM clinical trials and has amended the study protocol to allow enrollment of patients as young as four years of age and to include additional assessments such as functional MRI (fMRI) and improved color brightness tests.

Financial Results for the Three Months Ended September 30, 2020

R&D Expenses: Research and development expenses were $11.6 million for the quarter ended September 30, 2020 compared to $8.6 million during the comparable period in the prior fiscal year. The increase of $3.0 million was primarily due to increased external XLRP spending (primarily related to Skyline and Vista activities) and increased external spending related to ACHM (primarily due to patient enrollment and deployment of the Company’s mobile vision center). These expenses were partially offset by a reduction in employee-related costs and decreased external research and discovery spending on other programs.

G&A Expenses:   General and administrative expenses were $3.4 million for the quarter ended September 30, 2020 compared to $3.3 million during the comparable period in the prior fiscal year. The increase of $0.1 million was primarily due to higher fees from outside legal counsel in the 2020 period, partially offset by lower employee-related expenses and share-based compensation expense.

Interest Expense: Interest expense increased by $0.3 million during the quarter ended September 30, 2020 when compared to the comparable period in the prior fiscal year due to the loan agreement that the Company entered into on June 30, 2020.

Net Loss
: The Company’s net loss was $15.4 million and $11.6 million for the quarters ended September 30, 2020 and 2019, respectively.

Financial Guidance:   As of September 30, 2020, the Company’s cash, cash equivalents and investments totaled $66.6 million. We believe that these funds will be sufficient to allow the Company to generate data from its ongoing clinical programs, initiate the Skyline and Vista studies and fund currently planned research and discovery programs into the fourth quarter of calendar year 2021.

About AGTC
AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. The Company’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 & ACHM CNGA3). Its preclinical programs build on the Company’s industry-leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders.

About XLRP

XLRP is an inherited condition that causes progressive vision loss in boys and young men. Characteristics of the disease include night blindness in early childhood and progressive constriction of the visual field. In general, XLRP patients experience a gradual decline in visual acuity over the disease course, which results in legal blindness around the 4th or 5th decade of life. AGTC was granted U.S. Food and Drug Administration (FDA) orphan drug designation in 2017, as well as European Commission orphan medicinal product designation in 2016, for its gene therapy product candidate to treat XLRP caused by mutations in the RPGR gene.

About
ACHM

ACHM is an inherited retinal disease, which is present from birth and is characterized by the lack of cone photoreceptor function. The condition results in markedly reduced visual acuity, extreme light sensitivity causing day blindness, and complete loss of color discrimination. Best-corrected visual acuity in persons affected by ACHM, even under subdued light conditions, is usually about 20/200, a level at which people are considered legally blind.

Forward

Looking Statements

This release contains forward-looking statements that reflect AGTC’s plans, estimates, assumptions and beliefs, including statements regarding the
projected
timing for
its planned
Vista (
Phase 2/3 XLRP
)
and Skyline (Expanded Phase 1/2
XLRP
)
clinical tria
ls
, the timing for
reporting data
in both its
Skyline and Vista trials
and
the potential of
its
ACHM clinical programs
. Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic
, including the impact on its ability to enroll patients
. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to
a number of
important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on
the
C
ompany’s
business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading “Risk Factors” in
AGTC’s
most recent annual
and subsequently filed
quarterly report
s
filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

 
APPLIED GENETIC TECHNOLOGIES CORPORATION
BAL
ANCE SHEETS
(Unaudited)
             
    September 30,     June 30,  
In thousands, except per share data   2020     2020  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 31,570     $ 38,463  
Investments     34,987       41,995  
Prepaid and other current assets     1,984       2,506  
Total current assets     68,541       82,964  
Property and equipment, net     4,314       4,311  
Intangible assets, net     1,136       1,098  
Investment in Bionic Sight, LLC     8,067       8,096  
Right-of-use assets – operating leases     3,337       3,422  
Right-of-use asset – finance lease     69       80  
Other assets     151       348  
Total assets   $ 85,615     $ 100,319  
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 1,654     $ 1,355  
Accrued and other liabilities     10,246       10,502  
Lease liabilities – operating     1,063       1,058  
Lease liability – finance     49       48  
Total current liabilities     13,012       12,963  
Lease liabilities – operating, net of current portion     3,898       4,070  
Lease liability – finance, net of current portion     26       38  
Long-term debt, net of debt discounts and deferred financing fees     9,759       9,677  
Other liabilities     2,718       2,555  
Total liabilities     29,413       29,303  
Stockholders’ equity:                
Preferred stock, par value $0.001 per share, 5,000 shares authorized; no shares issued and outstanding            
Common stock, par value $0.001 per share, 150,000 shares authorized; 25,901 and 25,813 shares issued; 25,860 and 25,793 shares outstanding at September 30, 2020 and June 30, 2020, respectively     25       25  
Additional paid-in capital     253,208       252,519  
Treasury stock at cost; 41 and 20 shares at September 30, 2020 and June 30, 2020, respectively     (211 )     (88 )
Accumulated deficit     (196,820 )     (181,440 )
Total stockholders’ equity     56,202       71,016  
Total liabilities and stockholders’ equity   $ 85,615     $ 100,319  

 
APPLIED GENETIC TECHNOLOGIES CORPORATION
STATEMENTS OF OPERATIONS
(Unaudited)
 
    Three Months  
    Ended September 30,  
In thousands, except per share data   2020     2019  
Revenue:                
Collaboration revenue   $     $  
Grant revenue            
Total revenue            
Operating expenses:                
Research and development     11,626       8,642  
General and administrative and other     3,436       3,348  
Total operating expenses     15,062       11,990  
Loss from operations     (15,062 )     (11,990 )
Other income (expense), net:                
Investment income, net     64       446  
Interest expense     (332 )     (2 )
Total other income (expense), net     (268 )     444  
Loss before provision for income taxes     (15,330 )     (11,546 )
Provision for income taxes     21       21  
Loss before equity in net losses of an affiliate     (15,351 )     (11,567 )
Equity in net losses of an affiliate     (29 )     (10 )
Net loss   $ (15,380 )   $ (11,577 )
Weighted average shares outstanding:                
Basic     25,818       18,212  
Diluted     25,818       18,212  
Net loss per common share:                
Basic   $ (0.60 )   $ (0.64 )
Diluted   $ (0.60 )   $ (0.64 )
                 

IR/PR CONTACTS:
 

David Carey (IR) or Glenn Silver (PR)
Lazar FINN Partners
T: (212) 867-1768 or (646) 871-8485
[email protected] or [email protected]

Corporate Contacts:
Bill Sullivan
Chief Financial Officer
Applied Genetic Technologies Corporation
T: (617) 843-5728
[email protected]

Stephen Potter
Chief Business Officer
Applied Genetic Technologies Corporation
T: (617) 413-2754
[email protected]



AgeX Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update

AgeX Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update

  • Sublicensed stem cell line ESI-053 to ImStem Biotechnology for development of cell therapy candidate IMS001 for COVID-19 and acute respiratory distress syndrome from other causes.
  • Expanded agreement related to ESI clinical-grade pluripotent stem cell lines to provide AgeX independence to sublicense ESI lines to industry and academia for development of cellular therapeutics.

ALAMEDA, Calif.–(BUSINESS WIRE)–
AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a biotechnology company developing innovative regenerative therapeutics to treat human diseases to increase healthspan and combat the effects of aging, reported financial and operating results for the third quarter ended September 30, 2020.

Q3 Highlights

  • AgeX sublicensed stem cell line ESI-053 to ImStem Biotechnology, Inc., a biopharmaceutical company developing embryonic stem cell (ESC)-derived mesenchymal stem cells (MSCs), for development of cell therapy candidate IMS001 for COVID-19 and acute respiratory distress syndrome (ARDS). The sublicense grants ImStem a non-exclusive, royalty-bearing sublicense to use AgeX’s clinical-grade ESC line ESI-053 to derive ImStem’s investigational MSC product candidate IMS001 for development of treatments for COVID-19 and for ARDS from other causes. ImStem will endeavor to file one or more investigational new drug (IND) applications for IMS001 in COVID-19 and/or ARDS with the U.S. Food and Drug Administration (FDA) or equivalent EU regulatory agency within 18 months. Under the agreement, AgeX will be entitled to receive revenues in the form of royalties on the sale of IMS001, if successfully developed by ImStem and approved for marketing by the FDA or foreign regulatory authorities, as well as a share of certain other revenues that ImStem may receive in connection with the development or commercialization of IMS001 in COVID-19 and ARDS treatment.
  • AgeX, Lineage Cell Therapeutics and ES Cell International amended their License Agreement regarding ESI clinical-grade pluripotent stem cell lines for therapeutics purposes. The amendment secures AgeX independence to license out ESI cell lines as part of its collaboration and licensing model. The ESI stem cell lines are distinguished as the first clinical-grade human pluripotent stem cell lines created under current Good Manufacturing Practice as described in Cell Stem Cell (2007;1:490-4). They are listed on the National Institutes of Health (NIH) Stem Cell Registry and are among the best characterized and documented stem cell lines in the world. ESI cells are among only a few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA IND clearance for human studies.

“This quarter, we continued to build upon our licensing and collaboration model through our new agreement with ImStem that provides us an avenue for participating financially in potential treatments for COVID-19 and acute respiratory distress syndrome or ARDS. Since the first of the year, AgeX has entered into six agreements that could lead to the development of new cell therapies by our licensees and collaborators, which utilize our core technologies and cell lines with potential future income streams to AgeX,” said Greg Bailey M.D., Chairman of AgeX. “In addition, expansion of our agreement related to ESI clinical-grade pluripotent stem cell lines will now allow us independence to build ESI cell lines as a to-go-to source for deriving cell based therapeutics across the industry.”

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the “New Loan Agreement”) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. As of November 16, 2020, AgeX has borrowed $5.5 million and may draw additional funds from time to time subject to Juvenescence’s discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1.0 million in any single draw. More information about the New Loan Agreement can be found in AgeX’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for the periods ended March 31, 2020, June 30, 2020, and September 30, 2020 filed with the Securities and Exchange Commission on March 30, 2020, May 14, 2020, August 14, 2020, and November 16, 2020, respectively.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeX’s most recent projected cash flows, and considering that loans from Juvenescence under the New Loan Agreement will be subject to Juvenescence’s discretion, AgeX believes that its cash and cash equivalents, the remaining $2.5 million available under the New Loan Agreement and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeX’s Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

Third Quarter 2020 Operating Results

Revenues: Total revenues for the third quarter of 2020 were $434,000 as compared with $411,000 for the third quarter of 2019. AgeX revenues are primarily generated from subscription and advertising revenues from the GeneCards® online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $40,000 of allowable expenses under AgeX’s research grant from the NIH. Revenues from that grant were $41,000 in the same period in 2019.

Operating expenses: Operating expenses for the three months ended September 30, 2020 were $2.8 million as compared to $3.6 million for the same period in 2019. Operating expenses are comprised of research and development expense and general and administrative expenses. On an as-adjusted basis, operating expenses for the three months ended September 30, 2020 were $2.3 million as compared to $3.0 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses were $0.8 million during the three months ended September 30, 2020, a $0.6 million decrease from $1.4 million during the same period in 2019. The decrease was primarily attributable to the layoff of 11 research and development personnel in May 2020 and the elimination of shared services payments to Lineage Cell Therapeutics, Inc. (“Lineage”) with the termination of our Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses decreased by $0.3 million to $1.9 million during the three months ended September 30, 2020 from $2.2 million during the same period in 2019 despite an increase in head count resulting from the employment of AgeX’s own finance team commencing in October 1, 2019. These increases were offset by a decrease in noncash stock-based compensation expense, travel and related expenses with the shelter in place mandates since March 15, 2020 resulting from the COVID-19 pandemic, and the elimination of shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeX’s PureStem® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem® is AgeX’s delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of AgeX’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

 

 

September 30,

2020

 

 

December 31,

2019

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

1,107

 

 

$

2,352

 

Accounts and grants receivable, net

 

 

241

 

 

 

363

 

Prepaid expenses and other current assets

 

 

581

 

 

 

1,339

 

Total current assets

 

 

1,929

 

 

 

4,054

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

442

 

 

 

1,126

 

Deposits and other long-term assets

 

 

100

 

 

 

111

 

Intangible assets, net

 

 

1,732

 

 

 

2,151

 

TOTAL ASSETS

 

$

4,203

 

 

$

7,442

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

1,806

 

 

$

1,582

 

Loan due to Juvenescence, net of debt issuance cost, current portion

 

 

1,884

 

 

 

 

Related party payables, net

 

 

71

 

 

 

64

 

Deferred revenues

 

 

255

 

 

 

283

 

Right-of-use lease liability

 

 

109

 

 

 

428

 

Paycheck Protection Program Loan

 

 

435

 

 

 

 

Insurance premium liability and other current liabilities

 

 

294

 

 

 

940

 

Total current liabilities

 

 

4,854

 

 

 

3,297

 

 

 

 

 

 

 

 

 

 

Loan due to Juvenescence, net of debt issuance cost, net of current portion

 

 

3,095

 

 

 

1,528

 

TOTAL LIABILITIES

 

 

7,949

 

 

 

4,825

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding as of September 30, 2020 and December 31, 2019

 

 

 

 

 

 

Common stock, $0.0001 par value, 100,000 shares authorized; 37,689 and 37,649 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

90,880

 

 

 

88,353

 

Accumulated other comprehensive income

 

 

92

 

 

 

69

 

Accumulated deficit

 

 

(94,627

)

 

 

(86,208

)

AgeX Therapeutics, Inc. stockholders’ equity (deficit)

 

 

(3,651

)

 

 

2,218

 

Noncontrolling interest

 

 

(95

)

 

 

399

 

Total stockholders’ equity (deficit)

 

 

(3,746

)

 

 

2,617

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

$

4,203

 

 

$

7,442

 

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS, EXCEPT PER SHARE DATA)

(UNAUDITED)

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

REVENUES:

 

 

 

 

 

 

 

 

 

 

 

 

Subscription and advertisement revenues

 

$

309

 

 

$

278

 

 

$

945

 

 

$

898

 

Grant revenues

 

 

40

 

 

 

41

 

 

 

162

 

 

 

103

 

Other revenues

 

 

85

 

 

 

92

 

 

 

256

 

 

 

178

 

Total revenues

 

 

434

 

 

 

411

 

 

 

1,363

 

 

 

1,179

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

(50

)

 

 

(49

)

 

 

(120

)

 

 

(165

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

384

 

 

 

362

 

 

 

1,243

 

 

 

1,014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

839

 

 

 

1,447

 

 

 

3,792

 

 

 

4,435

 

General and administrative

 

 

1,949

 

 

 

2,194

 

 

 

5,675

 

 

 

6,422

 

Total operating expenses

 

 

2,788

 

 

 

3,641

 

 

 

9,467

 

 

 

10,857

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(2,404

)

 

 

(3,279

)

 

 

(8,224

)

 

 

(9,843

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER INCOME/(EXPENSES):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income (expense), net

 

 

(149

)

 

 

8

 

 

 

(288

)

 

 

53

 

Other income (expense), net

 

 

(12

)

 

 

48

 

 

 

(6

)

 

 

277

 

Total other income (expense), net

 

 

(161

)

 

 

56

 

 

 

(294

)

 

 

330

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS BEFORE INCOME TAXES

 

 

(2,565

)

 

 

(3,223

)

 

 

(8,518

)

 

 

(9,513

)

Income tax provision

 

 

 

 

 

(54

)

 

 

 

 

 

(130

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS

 

 

(2,565

)

 

 

(3,277

)

 

 

(8,518

)

 

 

(9,643

)

Net loss attributable to noncontrolling interest

 

 

22

 

 

 

56

 

 

 

99

 

 

 

200

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS ATTRIBUTABLE TO AGEX

 

$

(2,543

)

 

$

(3,221

)

 

$

(8,419

)

 

$

(9,443

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS PER COMMON SHARE:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BASIC AND DILUTED

 

$

(0.07

)

 

$

(0.09

)

 

$

(0.22

)

 

$

(0.25

)

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BASIC AND DILUTED

 

 

37,679

 

 

 

37,640

 

 

 

37,662

 

 

 

37,143

 

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

(UNAUDITED)

 

 

Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss attributable to AgeX

 

$

(8,419

)

 

$

(9,443

)

Net loss attributable to noncontrolling interest

 

 

(99

)

 

 

(200

)

Adjustments to reconcile net loss attributable to AgeX to net cash used in operating activities:

 

 

 

 

 

 

 

 

Gain on sale of equity method investment in Ascendance

 

 

 

 

 

(354

)

Depreciation expense

 

 

370

 

 

 

38

 

Amortization of intangible assets

 

 

419

 

 

 

419

 

Amortization of right-of-use asset

 

 

316

 

 

 

200

 

Amortization of debt issuance cost

 

 

277

 

 

 

17

 

Stock-based compensation

 

 

751

 

 

 

1,487

 

Foreign currency remeasurement gain (loss) and other

 

 

58

 

 

 

85

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts and grants receivable, net

 

 

94

 

 

 

(103

)

Prepaid expenses and other current assets

 

 

767

 

 

 

331

 

Accounts payable and accrued liabilities

 

 

237

 

 

 

319

 

Related party payables

 

 

16

 

 

 

187

 

Insurance premium liability

 

 

(713

)

 

 

(600

)

Deferred revenues and other liabilities

 

 

(271

)

 

 

(132

)

Net cash used in operating activities

 

 

(6,197

)

 

 

(7,749

)

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from the sale of equity method investment in Ascendance

 

 

 

 

 

354

 

Security deposit paid

 

 

 

 

 

(74

)

Purchase of equipment and other

 

 

(20

)

 

 

(346

)

Net cash used in investing activities

 

 

(20

)

 

 

(66

)

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from exercise of warrants

 

 

 

 

 

4,500

 

Draw down on loan facility from Juvenescence

 

 

4,700

 

 

 

500

 

Proceeds from Paycheck Protection Program Loan

 

 

433

 

 

 

 

Payment of debt related costs

 

 

(149

)

 

 

 

Repayment of financing lease liability

 

 

(15

)

 

 

(22

)

Net cash provided by financing activities

 

 

4,969

 

 

 

4,978

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

 

3

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

 

 

(1,245

)

 

 

(2,839

)

 

 

 

 

 

 

 

 

 

CASH, CASH EQUIVALENTS AND RESTRICTED CASH:

 

 

 

 

 

 

 

 

At beginning of the period

 

 

2,452

 

 

 

6,707

 

At end of the period

 

$

1,207

 

 

$

3,868

 

Non-GAAP Financial Measures

This press release includes operating expenses prepared in accordance with accounting principles generally accepted in the United States (GAAP) and, includes operating expenses, by entity, prepared in accordance with GAAP. This press release also includes certain historical non-GAAP operating expenses and non-GAAP operating expenses, by entity. In particular, AgeX Therapeutics, Inc. (“AgeX”) has provided both (a) non-GAAP total operating expenses, adjusted to exclude noncash stock-based compensation expense, depreciation and amortization expense, and acquired in-process research and development expense, a nonrecurring item, and (b) non-GAAP operating expenses, by entity, to exclude those same charges by the respective entities for consistency. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable financial measures prepared in accordance with GAAP. However, AgeX believes the presentation of non-GAAP total operating expenses and non-GAAP operating expenses, by entity, when viewed in conjunction with our GAAP total operating expenses, and GAAP operating expenses by entity, respectively, is helpful in understanding AgeX’s ongoing operating expenses and its programs and those of certain subsidiaries.

Furthermore, management uses these non-GAAP financial measures in the aggregate and on an entity basis to establish budgets and operational goals, to manage AgeX’s business and to evaluate its performance and its programs in clinical development.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

Reconciliation of Non-GAAP Financial Measure

Adjusted Operating Expenses

 

 

Amounts In Thousands and Unaudited

 

 

For the Three Months Ended

September 30,

 

For the Nine Months Ended

September 30,

 

 

2020

2019

 

2020

2019

 

GAAP Operating Expenses – as reported

$ 2,788

3,641

 

$ 9,467

$ 10,857

 

Stock-based compensation expense (1)

(232)

(491)

 

(751)

(1,487)

 

Depreciation and amortization expense (1)

(263)

(156)

 

(789)

(457)

 

Non-GAAP Operating Expenses, as adjusted

$ 2,293

$2,994

 

$ 7,927

$ 8,913

 

 

 

 

 

 

 

 

GAAP Operating Expenses – by entity

 

 

 

 

 

 

AgeX and subsidiaries other than LifeMap Sciences (2)

$ 2,449

$ 3,114

 

$ 7,955

$ 9,150

 

LifeMap Sciences, Inc. and subsidiary (3)

339

527

 

1,512

1,707

 

GAAP Operating Expenses – by entity

$ 2,788

$ 3,641

 

$ 9,467

$ 10,857

 

 

 

 

 

 

 

 

Non-GAAP Operating Expenses – as adjusted, by entity

 

 

 

 

 

 

AgeX and subsidiaries other than LifeMap Sciences

$ 2,066

$ 2,583

 

$ 6,755

$ 7,552

 

LifeMap Sciences, Inc. and subsidiary

227

411

 

1,172

1,361

 

Non-GAAP Operating Expenses – as adjusted, by entity

$ 2,293

$ 2,994

 

$ 7,927

$ 8,913

 

 

 

 

 

 

 

 

(1)

Noncash charges

(2)

AgeX Therapeutics, Inc. includes ReCyte Therapeutics, Inc., a majority-owned and consolidated subsidiary.

(3)

LifeMap Sciences Inc. includes LifeMap Sciences Ltd., both consolidated subsidiaries of AgeX Therapeutics, Inc.

 

Contact for AgeX:

Andrea Park

[email protected]

(510) 671-8620

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Health Stem Cells Pharmaceutical Clinical Trials

MEDIA:

Logo
Logo

Forte Biosciences, Inc. Reports Inducement Grants Under NASDAQ Listing Rules

Forte Biosciences, Inc. Reports Inducement Grants Under NASDAQ Listing Rules

TORRANCE, Calif.–(BUSINESS WIRE)–
Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, today announced the issuance of an equity inducement award as required by the Nasdaq Stock Market Rules.

In accordance with NASDAQ Listing Rule 5635(c)(4), the Compensation Committee of Forte’s Board of Directors approved the grant of an equity award to purchase 25,000 shares of common stock to a new non-executive employee as a material inducement to such individual’s accepting employment with the Company, with such award vesting over four years, with twenty-five percent vesting on the one-year anniversary of the grant date and the remaining seventy-five percent vesting in approximately equal monthly increments over the succeeding thirty-six months, subject to the individual’s continuous employment through each vesting date.

The Inducement Award was made outside of Forte’s current equity plan, under Forte’s 2020 Inducement Equity Incentive Plan and related award agreements, but will have terms and conditions generally consistent with those of Forte’s 2017 Equity Incentive Plan.

About Forte Biosciences, Inc.

Forte Biosciences, Inc. is a clinical stage, dermatology company developing a live biotherapeutic, FB-401, for the treatment of inflammatory skin diseases. FB-401 has completed Phase 1/2a testing in adult and pediatric (3 years of age and older) patients with atopic dermatitis and has initiated a Phase 2 clinical trial for FB-401. There is a significant unmet need for safe and effective therapies particularly for pediatric atopic dermatitis patients. In September 2020, Forte initiated a multi-center, placebo controlled clinical trial of FB-401 which is expected to enroll pediatric, adolescent and adult AD subjects aged 2 years of age and older. For additional information about the trial, see ClinicalTrials.gov using the identifier NCT04504279.

Forward Looking Statements

Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. Forward looking statements include statements regarding Forte’s beliefs, goals, intentions and expectations, and include statements regarding its ability to continue to advance its product candidates through the development process and achieve potential clinical development milestones in the future. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Forte’s ability to obtain sufficient additional capital to continue to advance the company’s product candidates and preclinical programs; unexpected costs, charges or expenses; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing product candidates; and risks associated with the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Source: Forte Biosciences, Inc.

Investors:

Forte Biosciences, Inc.

Paul Wagner, CEO

[email protected]

LifeSci Advisors

Mike Moyer, Managing Director

617.308.4306

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

MEDIA:

Histogen Announces Closing of $4.5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) — Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today announced the closing of its previously announced registered direct offering for the issuance and sale of 2,522,784 shares of its common stock, at a purchase price of $1.78375 per share. Histogen has also issued to investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,892,088 shares of its common stock. The offering was priced at-the-market under Nasdaq rules.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.70 per share, are exercisable immediately and will expire five and one-half years from the date of issuance.

The gross proceeds from this offering were approximately $4.5 million, before deducting placement agent’s fees and other offering expenses. Histogen intends to use the net proceeds from this offering for working capital and general corporate purposes, including expenses related to the clinical development of its products for its CCM, hECM and HSC programs, further research and development, capital expenditures and general and administrative expenses.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by Histogen pursuant to a “shelf” registration statement on Form S-3 (File No. 333-248074) previously filed with the Securities and Exchange Commission (the “SEC”) on August 17, 2020 and declared effective by the SEC on August 26, 2020. The offering of the shares of common stock only was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock was filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Histogen

Histogen Inc. is 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. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

Forward-Looking Information

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 the use of proceeds, our future operations and our ability to successfully initiate and complete clinical trials, obtain clinical trial data, and achieve regulatory milestones and related timing, including those related to the submission of a HST-003 IND for regeneration of cartilage in the knee, any initiation of a HST-002 Phase 1 trial for the treatment of moderate to severe nasolabial folds and the reporting of topline data for the ongoing HST-001 Phase 1a/2b trial for androgenic alopecia in men and the planned Phase 1 study of emricasan for the treatment of COVID-19; the nature, strategy and focus of our business; the sufficiency of our cash resources and ability to achieve value for our stockholders; and the development and commercial potential and potential benefits of any of our product candidates, such as HST-001, HST-002 and HST-003. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of ours that could differ materially from those described in or implied by the statements in this press release, including: market and other conditions, the uncertainties associated with the clinical development and regulatory approval of our product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of our 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 our 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 our filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim 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.

Contact:

Susan A. Knudson
Executive Vice President & CFO
Histogen Inc.
[email protected] 



AXT Announces Strategic Plan to Access China’s Capital Markets

Subsidiaries Take First Step Towards an IPO in China

Private Equity Round Underway

  • Process initiated to list shares of subsidiary, Tongmei, on China’s STAR Market
  • Two raw material companies to be merged into Tongmei
  • Definitive agreements executed for initial private placement of shares of Tongmei to meet listing requirements
  • AXT to maintain its Nasdaq listing; its Fremont, Calif. headquarters; and its focus on global opportunities
  • Conference call to discuss the announcement today at 2:30 pm PT. Details included in this release

FREMONT, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — AXT, Inc. (NasdaqGS: AXTI), a leading manufacturer of compound semiconductor substrates, today announced a strategic plan to access China’s capital markets in order to enhance its ability to support at scale the strong, expected demand for strategic compound semiconductor materials and to continue to elevate its business and manufacturing operations in support of Tier-1 customer requirements, as well as to replenish its cash with minimal dilution and further strengthen its financial structure.

AXT plans to merge two of its raw material companies into its wafer manufacturing company in China, Beijing Tongmei Xtal Technology Co., Ltd. (“Tongmei”), subject to completion of definitive documentation and applicable laws. The two raw material companies, Beijing BoYu Semiconductor Vessel Craftwork Technology Co., Ltd. (“BoYu”) and Nanjing JinMei Gallium Co., Ltd. (“JinMei”), and their related entities in China are performing well and add breadth of product diversity to Tongmei.

AXT will seek to list shares of Tongmei on the Shanghai Stock Exchange’s Sci-Tech innovAtion boaRd (the “STAR Market”), an exchange intended to support innovative companies in China. The process of going public on the STAR Market includes several periods of review and, therefore, is a lengthy process. Tongmei does not expect to accomplish this goal until mid-2022.

The listing of Tongmei on China’s STAR market will not change the status of AXT, Inc. as a U.S. public company. It is a U.S. company, headquartered in Fremont, California. It will continue to be listed on the Nasdaq Global Select Market under the symbol AXTI.

To qualify for a STAR Market listing, Tongmei is required to have multiple independent shareholders. The first major step in this process is engaging reputable private equity firms in China to invest funds in Tongmei. In exchange for approximately a 7.14 percent minority interest in Tongmei, private equity firms will invest approximately $50 million. The first tranche investment documents were executed on November 13, 2020 in China and the first tranche of approximately $22.5 million is expected to be received in late November or early December 2020. The second tranche of approximately $26.5 million is expected to fund in January 2021. The second tranche investment documents have not yet been executed. AXT’s ability to retain these investments is contingent upon a successful completion of the STAR Market listing. Tongmei would be required to sell a minimum of 10 percent of its equity in the public offering, bringing the total minority interest held publicly to approximately 17.14 percent, or greater if Tongmei elects to increase the offering above 10 percent.

“Pursuing a listing on the STAR Market gives us the ability to replenish our cash and increase our market value for our shareholders with minimal dilution,” said Morris Young, chief executive officer. “Further, the additional capital will strengthen our ability to compete for larger business opportunities. We have largely completed the relocation of our manufacturing lines and now our market-leading portfolio of materials is intersecting with what we believe to be some of the biggest, most influential technology trends of the next decade, such as 5G telecommunications, data center connectivity, LED-based lighting and display, and laser-based sensing. In addition to these opportunities, we believe new applications across our portfolio are creating exciting incremental opportunities on the horizon. Strengthening our balance sheet can give our customers greater confidence in our ability to support at scale the strong, expected demand for our strategic compound semiconductor materials.”

BoYu manufactures pyrolytic boron nitride (pBN) crucibles that are used when growing single-crystal compound semiconductor ingots and used as effusion rings growing OLED tools. JinMei produces 7N+ purified gallium and other specialty materials.

“The combination of AXT’s wafer manufacturing with BoYu’s and JinMei’s products and capabilities presents a compelling and well-rounded business model,” Young continued. “They synergistically serve a diverse set of customers and markets, providing world-class materials to the semiconductor industry. We believe that the convergence of a strong market opportunity with state-of-the-art manufacturing capabilities and a diverse portfolio of products will make Tongmei an attractive company for the STAR Market and create incremental value for our shareholders.”

Conference Call

The company will host a conference call to discuss these results today at 2:30 p.m. PT. The conference call can be accessed at (844) 892-6598 (passcode 7117157). The call will also be simulcast at www.axt.com. Replays will be available at (855) 859-2056 (passcode 7117157) until, November 22, 2020. Additional investor information can be accessed at http://www.axt.com or by calling the company’s Investor Relations Department at (510) 438-4700.

About AXT, Inc.

AXT is a material science company that develops and manufactures high-performance compound and single element semiconductor substrate wafers comprising indium phosphide (InP), gallium arsenide (GaAs) and germanium (Ge). The company’s substrate wafers are used when a typical silicon substrate wafer cannot meet the performance requirements of a semiconductor or optoelectronic device. End markets include 5G infrastructure, data center connectivity (silicon photonics), passive optical networks, LED lighting, lasers, sensors, power amplifiers for wireless devices and satellite solar cells. AXT’s worldwide headquarters are in Fremont, California where the company maintains its sales, administration and customer service functions. AXT has manufacturing facilities in China and, as part of its supply chain strategy, has partial ownership in ten companies in China producing raw materials. For more information, see AXT’s website at http://www.axt.com.

Fo
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Looking
Statement
s

The foregoing paragraphs contain forward-looking statements within the meaning of the Federal securities laws, including, for example, statements regarding AXT’s plan to merge Tongmei, its wafer manufacturing company in China, with Boyu and Jinmei, Tongmei receiving the first tranche of private equity investment funds, signing investment documents to secure the second tranche of private equity investment funds into Tongmei and subsequently receiving such funds, completing other preliminary steps in connection with the proposed listing of shares of Tongmei on the STAR Market, being accepted to list shares of Tongmei on the STAR Market and the timing and completion of such listing of shares of Tongmei on the STAR Market. Additional examples of forward-looking statements include statements regarding the market demand for our products, our growth prospects and opportunities for continued business expansion, including technology trends and new applications, our market opportunity and ability to compete for business opportunities, elevating our manufacturing, enhancing our business processes and financial structure, our relocation and our expectations with respect to our business prospects and financial results. These forward-looking statements are based upon assumptions that are subject to uncertainties and factors relating to the company’s operations and business environment, which could cause actual results to differ materially from those expressed or implied in the forward-looking statements contained in the foregoing discussion. These uncertainties and factors include, but are not limited to: the tax and legal consequences of merging Tongmei with Boyu and Jinmei, the lack of interest of private equity funds in China to invest in Tongmei, the withdrawal, cancellations or requests for redemptions by private equity funds in China of investments in Tongmei, the timing of receipt of private equity funds into Tongmei, the administrative challenges in satisfying the requirements of various government agencies in China in connection with the investments in Tongmei and the listing of shares of Tongmei on the STAR Market, continued open access to companies to list shares on the STAR Market, investor enthusiasm for new listings of shares on the STAR Market and geopolitical tensions between China and the United States. Additional uncertainties and factors include, but are not limited to, the timing and receipt of significant orders; the cancellation of orders and return of product; emerging applications using chips or devices fabricated on our substrates; end-user acceptance of products containing chips or devices fabricated on our substrates; our ability to bring new products to market; product announcements by our competitors; the ability to control costs and improve efficiency; the ability to utilize our manufacturing capacity; product yields and their impact on gross margins; the relocation of manufacturing lines and ramping of production; possible factory shutdowns as a result of air pollution in China; COVID-19 or other outbreaks of a contagious disease; tariffs and other trade war issues; the financial performance of our partially owned supply chain companies; policies and regulations in China; and other factors as set forth in the company’s Annual Report on Form 10-K, quarterly reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Each of these factors is difficult to predict and many are beyond the company’s control. The company does not undertake any obligation to update any forward-looking statement, as a result of new information, future events or otherwise.

Contacts:
Gary Fischer
Chief Financial Officer
(510) 438-4700

Leslie Green                
Green Communications Consulting, LLC
(650) 312-9060



Aravive to Present at the Piper Sandler 32nd Annual Virtual Healthcare Conference

HOUSTON, Nov. 16, 2020 (GLOBE NEWSWIRE) — Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced the Company will present and conduct one-on-one meetings with investors at the Piper Sandler 32nd Annual Virtual Healthcare Conference. Aravive’s presentation will be available for viewing beginning on November 23, 2020 and senior management will participate in one-on-one meetings on December 3, 2020.

The webcast and audio archive of the presentation will be available at http://ir.aravive.com. An archived replay of the webcast will be available for 90 days following the presentation.

About Aravive

Aravive, Inc. is a clinical-stage oncology company developing transformative therapeutics designed to halt the progression of life-threatening diseases. Aravive’s lead therapeutic, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive recently successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and selected 15 mg/kg as the dose for the pivotal trial. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals. While the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer was a safety trial and not powered to demonstrate efficacy, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. The Company also intends to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year. For more information, please visit www.aravive.com.

Contacts:

Media:

Sheryl Seapy, W2O
[email protected]
(213) 262-9390

Investors:

Luke Heagle, W2O
[email protected]
(910) 726-1372