Catalent Announces Upsizing and Pricing of Private Offering of Senior Unsecured Notes Due 2030

Catalent Announces Upsizing and Pricing of Private Offering of Senior Unsecured Notes Due 2030




Catalent Announces Upsizing and Pricing of Private Offering of Senior Unsecured Notes Due 2030

SOMERSET, N.J.–(BUSINESS WIRE)–Catalent, Inc. (“Catalent”) (NYSE: CTLT), the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics; cell and gene therapies; and consumer health products, today announced that its wholly owned subsidiary, Catalent Pharma Solutions, Inc. (the “Operating Subsidiary”), priced a private offering (the “Private Offering”) of $650 million in aggregate principal amount of 3.500% senior unsecured notes due 2030 (the “Notes”) at par, which represents an increase of $200 million from the offering size previously announced.

The Operating Subsidiary intends to use the proceeds from the Private Offering to finance a portion of the purchase price for the previously announced acquisition of Bettera Holdings, LLC (the “Bettera Acquisition”) and to pay related fees, costs, and expenses.

The Notes will be guaranteed by all of the wholly owned U.S. subsidiaries of the Operating Subsidiary that guarantee its senior secured credit facilities. The Notes will not be guaranteed by PTS Intermediate Holdings, LLC or Catalent, the direct and indirect parent companies of the Operating Subsidiary.

The Private Offering is exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”). The Notes will be offered and sold to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and to certain non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act.

The sale of the Notes is expected to be consummated on September 29, 2021, subject to customary closing conditions.

The Notes have not been and will not be registered under the Securities Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Notes or any other securities described above and shall not constitute an offer, solicitation or sale in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful.

About Catalent

Catalent, Inc. (NYSE: CTLT), an S&P 500® Company, is the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics; cell and gene therapies; and consumer health products. With almost 90 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply. Catalent’s workforce exceeds 17,000 people, including more than 2,500 scientists and technicians, at more than 50 facilities on four continents, and in fiscal year 2021, it generated $4 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

Forward-Looking Statement Notice

This release contains both historical and forward-looking statements, including statements regarding the Bettera Acquisition, the Private Offering and plans, projections and estimates regarding the use of proceeds from the Private Offering. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified because they relate to the topics set forth above or by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the current or future effects of the COVID-19 pandemic on Catalent’s or its clients’ or suppliers’ businesses, participation in a highly competitive market and increased competition may adversely affect Catalent’s business; demand for Catalent’s offerings which depends in part on Catalent’s customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity, and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political, and regulatory risks to the operations of Catalent; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks, and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components, and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies; adverse tax legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisition, including the Bettera Acquisition, or other transaction that may complement or expand Catalent’s business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at Catalent’s existing facilities; offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health, and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to fund Catalent’s existing pension plans; substantial leverage resulting in the limited ability of Catalent to raise additional capital to fund operations and react to changes in the economy or in the industry; exposure to interest rate risk to the extent of Catalent’s variable rate debt and preventing Catalent from meeting its obligations under its indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in Catalent’s Annual Report on Form 10-K for the fiscal year ended June 30, 2021, filed August 30, 2021. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.

Contacts

Catalent, Inc.

Investor Contact:

Paul Surdez, 732-537-6325

investors@catalent.com

Brooklyn ImmunoTherapeutics Reports Inducement Grants

Brooklyn ImmunoTherapeutics Reports Inducement Grants




Brooklyn ImmunoTherapeutics Reports Inducement Grants

NEW YORK, Sept. 23, 2021 (GLOBE NEWSWIRE) — Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) (“Brooklyn”), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases, today announced that on September 20, 2021, Roger Sidhu was granted a non-qualified stock option covering 161,300 shares of Brooklyn’s common stock (the “Time-Based Option”) and a restricted stock unit covering 80,650 shares of Brooklyn’s common stock (the “RSU”).

The Time-Based Option will have a per share exercise price equal to the closing price of a share of Brooklyn’s common stock on the NYSE American Stock Exchange on September 20, 2021. Of the shares covered by the Time-Based Option, twenty-five percent of the shares will vest on September 20, 2022, and 1/36 of the remaining shares will vest on the twentieth day of each calendar month from October 20, 2022 through September 20, 2025, in each case for so long as Dr. Sidhu provides continuous service to Brooklyn through the relevant vesting date.

The RSU will vest in four equal installments, with one-fourth of the shares covered by such RSU vesting on the anniversary of the grant date in each of 2022, 2023, 2024 and 2025, in each case for so long as Dr. Sidhu provides continuous service to Brooklyn through the relevant vesting date.

The unvested portion of the Time-Based Option and the RSU will terminate upon the termination of Dr. Sidhu’s employment with Brooklyn for any reason, subject to certain vesting acceleration provisions upon a qualifying termination, as described in his employment agreement with Brooklyn. Unless earlier terminated in accordance with their terms, each of the Time-Based Option and the RSU will otherwise expire on the tenth anniversary of the grant date and be subject to the terms and conditions of the respective option agreement approved by Brooklyn. Each of the Time-Based Option and the RSU is intended to constitute an “employment inducement grant” in accordance with the employment inducement grant rules set forth in Section 711(a) of the NYSE American LLC Company Guide, and is offered as an inducement material to Dr. Sidhu in connection with Brooklyn’s hiring of Dr. Sidhu. Both of the equity awards described above were granted pursuant to the Company’s 2021 Inducement Stock Incentive Plan, which was not subject to stockholder approval.

About Brooklyn ImmunoTherapeutics

Brooklyn is focused on exploring the role that cytokine, gene editing, and cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases.

Brooklyn’s most advanced program is IRX-2, a human cell-derived cytokine therapy, studying the safety and efficacy of IRX-2 in patients with head and neck cancer in Phase 2B. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

Brooklyn has multiple next-generation cell and gene-editing therapies in preclinical development for various indications including acute respiratory distress syndrome, solid tumor indications, as well as in vivo gene-editing therapies for rare genetic diseases. For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.com.

Investor Relations Contact:
CORE IR
516-222-2560
investors@brooklynitx.com

Media Contact:
CORE IR
Jules Abraham
917-885-7378
julesa@coreir.com 

Medicenna Appoints Dr. John H. Sampson to its Board of Directors

Medicenna Appoints Dr. John H. Sampson to its Board of Directors




Medicenna Appoints Dr. John H. Sampson to its Board of Directors

Announces Results of Annual Meeting of Shareholders

TORONTO and HOUSTON, Sept. 23, 2021 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (NASDAQ: MDNA TSX: MDNA), a clinical stage immuno-oncology company, today announced the appointment of John H. Sampson, MD, PhD, MBA, to its Board of Directors and the voting results from the Company’s annual meeting of shareholders held today, September 23, 2021 (the “Meeting”).

“John is a world-renowned clinician-scientist and I’m thrilled to welcome him to our Board,” said Fahar Merchant, PhD, President and CEO of Medicenna. “We believe his extensive background in leading novel clinical trials, interactions with regulators and translational immuno-oncology expertise will be invaluable as we work to further develop MDNA11, advance our MDNA55 program with a partnership, and leverage our Superkine platform to bring additional candidates into the clinic. We look forward to his guidance and contributions to advancing our pipeline into the clinic.”

Dr. Sampson added, “This is an exciting time for Medicenna and it’s an honor to be joining the Board. With the recent initiation of the Phase 1/2 ABILITY Study, the Company is on track to begin demonstrating the potential of MDNA11 in the clinic. It also has impressive Phase 2b data with MDNA55 in recurrent glioblastoma and a highly talented management team, all of which position the Company for continued success.”   

John H. Sampson, MD, PhD, MBA, is the Robert H. and Gloria Wilkins Distinguished Professor of Neurosurgery at Duke University School of Medicine. He is also President of Private Diagnostic Clinic, Duke’s physician practice with revenue of over $1 billion and a member of the prestigious National Academy of Medicine. He has served on multiple Scientific and Governance Boards at publicly traded biotechnology companies and major non-profit health delivery organizations. Dr. Sampson is the National Institutes of Health’s top funded neurosurgeon, has helped develop various immune-based therapies, and has served as the lead investigator in dozens of early and late-stage clinical trials. He has published more than 270 peer-reviewed papers in journals such as Nature, Journal of the American Medical Association, and Proceedings of the National Academy of Sciences, and has been an editorial board member for major journals in his field. As part of his research efforts, he is actively investigating new modalities of direct brain tumor infusion and the development of novel immunotherapies. Dr. Sampson has an MD from the University of Manitoba, a PhD from Duke University, and an MBA from Duke’s Fuqua School of Business. 

Medicenna is also pleased to announce that all of the nominees listed in the management proxy circular dated August 20, 2021 were elected as directors.  Each of the directors was elected with greater than 97% of the votes cast by shareholders present at the Meeting or represented by proxy. The results of the vote are detailed below:

Nominee Votes For % of
Votes For
Votes
Withheld
% of Votes
Withheld
Dr. Fahar Merchant 21,912,501 99.324 149,186 0.676%
Mr. Albert Beraldo 22,041,012 99.906 20,675 0.094%
Ms. Karen Dawes 21,945,392 99.473 116,295 0.527%
Dr. John (Jack) Geltosky 21,948,897 99.489 112,790 0.511%
Ms. Rosemina Merchant 21,946,259 99.477 115,428 0.523%
Dr. Chandrakant Panchal 21,589,617 97.860 472,070 2.140%
Dr. John Sampson 22,044,077 99.920 17,610 0.080%

Medicenna shareholders also voted to appoint PricewaterhouseCoopers LLP as auditor of the Company.

A total of 51.408% of the issued and outstanding common shares of the Company were represented in person and by proxy at the Meeting.

About Medicenna
Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 binding without CD25 affinity thereby preferentially stimulating cancer killing effector T cells and NK cells. Medicenna’s early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors. Medicenna’s IL-4 Empowered Superkine, MDNA55, has been studied in 5 clinical trials including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively.

Forward-Looking Statement
This news release contains forward-looking statements within the meaning of applicable securities laws and relate to the future operations of the Company and other statements that are not historical facts including statements related to the potential impact of Dr. Sampson or any other individual director on the Company’s clinical study and trial programs, interactions with regulatory bodies and prospects generally; the enrollment, expansion, prospects and timing of regulatory submissions and results for its Phase 1/2 ABILITY study; its timeline, design and expansion, the clinical potential of MDNA11; the prospects and potential partnerships for MDNA55; and the Company’s general growth opportunities and potential. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects”, “believes”, “seeks” and similar expressions. All statements other than statements of historical fact, included in this release, including the future plans and objectives of the Company, are forward-looking statements that are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the annual information form and Form 40-F of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada and the United States.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. Except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.

CONTACT: Further Information

For further information about the Company please contact:

Elizabeth Williams, Chief Financial Officer, 416-648-5555, ewilliams@medicenna.com   

Investor Contact

For more investor information, please contact:

Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, daniel@lifesciadvisors.com

vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis

vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis




vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis

HPP737 exhibited favorable safety and tolerability profile, with no dose limiting gastrointestinal side effects

Results build on data from previous multiple ascending dose study and support advancement of HPP737 into Phase 2 in moderate to severe psoriasis.

Successful pre-IND meeting with U.S. Food and Drug Administration Division of Dermatology and Dentistry supports planned IND submission for a Phase 2 study in moderate to severe psoriasis.

HIGH POINT, N.C., Sept. 23, 2021 (GLOBE NEWSWIRE) — vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced results of a multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 (“PDE4”) inhibitor, in healthy adults. The trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo (3:1) orally once daily for 14 days. Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events. vTv therefore believes that the current safety profile allows it to move forward in development with a drug that may achieve anti-inflammatory and anti-psoriatic responses without the significant safety issues of other PDE4 inhibitors. Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.

With these results, vTv held a successful pre-IND meeting with the U.S. Food and Drug Administration Division of Dermatology and Dentistry. As a key outcome of the meeting, the Company obtained acknowledgement that the completed studies appear reasonable to support the proposed dosing regimen of 20mg/day for 12 weeks. In addition, the Company obtained feedback on the proposed safety monitoring and clinical trial endpoints. vTv plans to file an IND application later this year for a 12-week Phase 2 clinical trial evaluating the safety and efficacy of HPP737 in patients with moderate to severe psoriasis with study initiation targeted for early 2022.

“We are pleased that the study accomplished its objectives by confirming the anticipated favorable safety and tolerability profile of HPP737, particularly the absence of dose limiting gastrointestinal adverse events, at substantially higher concentrations than previously tested,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “An oral, once-daily PDE4 inhibitor with robust efficacy, absent adverse events of gastrointestinal distress, would be a significant benefit for patients with psoriasis. With FDA’s feedback on our trial design we look forward to submitting the IND and beginning the Phase 2 trial in early 2022.”

In addition to the Company’s planned Phase 2 study in moderate to severe psoriasis, Newsoara Biopharma, the Company’s strategic partner in Asia, is currently conducting Phase 2 studies in chronic obstructive pulmonary disease (COPD), psoriasis, and atopic dermatitis in China.

About HPP737
HPP737 is a novel, potent, orally administered PDE4 inhibitor discovered by vTv Therapeutics. HPP737 has been tested by vTv in three Phase 1 healthy volunteer clinical trials to date under an IND with the Division of Pulmonology, Allergy and Critical Care. HPP737 has been well tolerated across the range of doses tested, with few or no gastrointestinal adverse events, such as nausea, vomiting or diarrhea. vTv is filing a new IND for HPP737 with the Division of Dermatology and Dentistry to pursue HPP737 as a treatment for moderate-to-severe psoriasis.

About Psoriasis
Psoriasis is a chronic autoimmune inflammatory disease that impacts the skin and joints due to an imbalance of inflammatory cytokines. This results in the development of raised, red, silvery scale plaques on the skin (i.e. plaque psoriasis, psoriasis vulgaris) that has both medical implications and an impact on a patient’s quality of life. While the specific trigger for this inflammatory imbalance is unknown, psoriasis may be caused by autoimmunity and genetic predisposition. Events such as trauma to the skin, stress, illness or infection that triggers the immune system, obesity, and weather have all been identified as contributing factors.

About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and psoriasis. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

Forward-Looking Statements
This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

Contacts

Investors:

Corey Davis
LifeSci Advisors
CDavis@LifeSciAdvisors.com

or

Media:

PR@vtvtherapeutics.com 

Source: vTv Therapeutics Inc.

Treace Announces New ALIGN3D™ Data at the 2021 AOFAS Annual Meeting

Treace Announces New ALIGN3D™ Data at the 2021 AOFAS Annual Meeting




Treace Announces New ALIGN3D™ Data at the 2021 AOFAS Annual Meeting

PONTE VEDRA, Fla., Sept. 23, 2021 (GLOBE NEWSWIRE) — Treace Medical Concepts, Inc. (“Treace”) (Nasdaq: TMCI), a commercial-stage orthopaedic medical device company driving a paradigm shift in the surgical treatment of hallux valgus (commonly known as bunions) through its Lapiplasty® 3D Bunion Correction™ procedure, today announced the presentation of new data at the ongoing 2021 American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting in Charlotte, North Carolina. Updated interim analysis from the ALIGN3D™ clinical study demonstrated positive radiographic and patient-reported outcomes starting at 6 weeks and maintained at 24 months following the Lapiplasty® procedure.

“Results of an Interim Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing” was highlighted during the poster presentations. Data on 151 study participants showed:

  • Early return to weight bearing in a walking boot at an average 8.3 days;
  • Significant improvement in radiographic measures of 3-dimensional bunion correction and patient reported pain reduction and quality of life measurements at 12 months (n=104) and through 24 months (n=28) following the Lapiplasty® procedure;
  • Return to work within 4 weeks and to full, unrestricted activity within 4.1 months of procedure; and
  • Low recurrence rate maintained; 0.9% recurrence rate observed (1 out of 104 patients) at 12 months post-surgery.

John T. Treace, CEO of Treace commented, “New data continues to demonstrate sustained successful procedural and patient outcomes from our proprietary Lapiplasty® System, specifically designed to address the unmet needs of bunion patients. We are pleased with our growing body of clinical evidence that support our differentiated solution, as we advance the standard of care for bunion surgery with our proprietary Lapiplasty® procedure.”

A poster summarizing the data and conclusions can be accessed by meeting attendees through the AOFAS mobile app.

About the ALIGN3D™ Clinical Study
The ALIGN3D™ clinical study is a prospective, multicenter, post-market study designed to evaluate outcomes of Lapiplasty® 3D Bunion Correction™ in the surgical management of symptomatic hallux valgus. The study will evaluate for consistent and reliable correction of all three dimensions of the bunion deformity with the Lapiplasty® Procedure, as well as maintenance of such correction following accelerated return to weight-bearing, initially in a walking boot. The primary effectiveness endpoint is radiographic recurrence of the hallux valgus deformity at 24 months follow up. Key secondary endpoints include change in three-dimensional radiographic alignment; clinical radiographic healing; time to start of weight-bearing in a boot and in shoes; pain; quality of life; and range of motion of the big toe joint. The study enrolled 173 patients, aged 14 to 58 years, at 7 clinical sites in the United States with 13 participating surgeons. Final patient follow-up for the primary endpoint is anticipated in the first half of 2023.

About Treace Medical Concepts
Treace Medical Concepts, Inc. is a commercial-stage orthopaedic medical device company with the goal of advancing the standard of care for the surgical management of bunion deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot. Treace has pioneered and patented the Lapiplasty® 3D Bunion Correction™ system – a combination of instruments, implants, and surgical methods designed to correct all 3 planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and getting patients back to their active lives quickly.

About AOFAS Annual Meeting
The American Orthopaedic Foot & Ankle Society® (AOFAS) mobilizes its global community of foot and ankle orthopaedic specialists to improve patient care through education, research, and advocacy. The AOFAS Annual Meeting is the premier event for foot and ankle education, offering presentations from renowned speakers, special interest forums, social events, and the latest products and technology.

Contacts:
Treace Medical Concepts
Mark L. Hair
Chief Financial Officer
mhair@treace.net
(904) 373-5940

Investors:
Gilmartin Group
Lynn Lewis or Vivian Cervantes
IR@treace.net

Ocugen, Inc. to Participate in Fireside Chat at the Cantor Virtual Global Healthcare Conference

Ocugen, Inc. to Participate in Fireside Chat at the Cantor Virtual Global Healthcare Conference




Ocugen, Inc. to Participate in Fireside Chat at the Cantor Virtual Global Healthcare Conference

MALVERN, Pa., Sept. 23, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, today announced that its Chairman, CEO, and Co-Founder, Dr. Shankar Musunuri, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 8 a.m. Eastern Time. Dr. Musunuri will discuss COVAXIN™, the investigational COVID-19 vaccine which the company is co-developing with Bharat Biotech for the U.S. and Canadian markets. He will also present information about Ocugen’s breakthrough modifier gene therapy platform, which has generated product candidates that are expected to enter Phase 1/2a clinical trials in ophthalmic disease states over the next 18 months.

The fireside chat can be viewed live at https://wsw.com/webcast/cantor12/ocgn/2072070 and will be available within Ocugen’s Investor Relations page found at https://ir.ocugen.com.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug — “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as risks and uncertainties regarding market and other conditions and the timing of our planned clinical trials. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. 

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

Novālent is Now Available at Walmart Inc.

Novālent is Now Available at Walmart Inc.




Novālent is Now Available at Walmart Inc.

GREENSBORO, N.C.–(BUSINESS WIRE)–Novālent Biotech, Inc (‘Novālent’), a U.S. biotechnology engineering firm, is pleased to announce that after a nine-month review Novālent long lasting surface protection technology is available at Walmart stores in the United States.

“Walmart is an important distribution partner given its unparallel scale and reach,” said Kevin Parrish, Novālent CEO. “By having our technology available readily throughout the US now means clients of all sizes can benefit from Novālent’s patented long-lasting protection.”

Novālent technology is based on a patented, non-toxic monomolecular layer that continuously kills germs for up to 90 days on surfaces, and is used by leading firms in the US and around the world to help provide an additional layer of protection not available through standard disinfection.

Novālent technology is available both online and in select stores, with a full roll out commencing over the course of the next 30 days.

About Novālent

Novālent® is a leading US biotechnology engineering firm which has pioneered the development of long-lasting technology to protect against germs. Novālent® technology is based on a patented, non-toxic monomolecular layer that continuously kills germs for up to 90 days on surfaces and up to 24 hours on human skin after application. Used by leading US firms including PepsiCo, Pilgrims and HanesBrands, Novālent is private equity backed and is headquartered in Greensboro, North Carolina, with sales offices around the world. For more information on Novālent, visit www.novalent.com.

Contacts

Christine Wetzler christine@pietrylapr.com

ModivCare to Present at Deutsche Bank’s 29th Annual Leveraged Finance Conference

ModivCare to Present at Deutsche Bank’s 29th Annual Leveraged Finance Conference




ModivCare to Present at Deutsche Bank’s 29th Annual Leveraged Finance Conference

DENVER–(BUSINESS WIRE)–ModivCare Inc. (“ModivCare” or the “Company”) (Nasdaq: MODV), a technology-enabled healthcare services company that provides a suite of integrated supportive care solutions focused on improving patient outcomes, today announced that Heath Sampson, Chief Financial Officer, is scheduled to present at Deutsche Bank’s 29th Annual Leveraged Finance Conference, which is being held virtually, on Monday, October 4, 2021 at 3:15 pm ET.

A webcast of the presentation will be accessible on the Company’s website at: https://investors.modivcare.com/events-presentations/default.aspx.

ModivCare also will be participating in one-on-one meetings throughout the day.

About ModivCare

ModivCare Inc. (“ModivCare”) (Nasdaq: MODV) is a technology-enabled healthcare services company that provides a suite of integrated supportive care solutions for public and private payors and their patients. Our value-based solutions address the social determinants of health (SDoH), enable greater access to care, reduce costs, and improve outcomes. We are a leading provider of non-emergency medical transportation (NEMT), personal and home care, and nutritional meal delivery. ModivCare also holds a minority equity interest in CCHN Group Holdings, Inc. and its subsidiaries (“Matrix Medical Network”), which partners with leading health plans and providers nationally, delivering a broad array of assessment and care management services to individuals that improve health outcomes and health plan financial performance. To learn more about ModivCare, please visit www.modivcare.com.

Contacts

Media:
Kate Zerone

Senior Manager, Communications

kate.zerone@modivcare.com

Investors:
The Equity Group

Kalle Ahl, CFA

kahl@equityny.com

Astex Pharmaceuticals Presents Overall Survival Data From ASCERTAIN Phase 3 Study of Oral Hypomethylating Agent INQOVI® (decitabine and cedazuridine) in MDS and CMML at International Congress on Myelodysplastic Syndromes

Astex Pharmaceuticals Presents Overall Survival Data From ASCERTAIN Phase 3 Study of Oral Hypomethylating Agent INQOVI® (decitabine and cedazuridine) in MDS and CMML at International Congress on Myelodysplastic Syndromes




Astex Pharmaceuticals Presents Overall Survival Data From ASCERTAIN Phase 3 Study of Oral Hypomethylating Agent INQOVI® (decitabine and cedazuridine) in MDS and CMML at International Congress on Myelodysplastic Syndromes

  • Study achieved median overall survival of 31.7 months
  • Updated efficacy data demonstrated an overall response rate of 62%, with 22% of patients achieving a complete response
  • INQOVI is the only oral hypomethylating agent with equivalent exposure to its intravenous (IV) form

PLEASANTON, Calif.–(BUSINESS WIRE)–Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, today announced updated clinical data, including median overall survival (mOS), from the ASCERTAIN phase 3 trial of INQOVI®, the company’s orally administered fixed-dose combination of decitabine and cedazuridine (ASTX727 or DEC-C) in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). mOS was 31.7 months.

The data were featured in a presentation given today at the 16th International Congress on Myelodysplastic Syndromes in Toronto, Canada, by Michael Savona, MD, Professor of Medicine and Cancer Biology, Department of Internal Medicine at Vanderbilt University School of Medicine, Tenn., on behalf of the study investigators.

The ASCERTAIN clinical trial was designed as a randomized crossover study comparing oral decitabine (35mg) and cedazuridine (100mg) fixed-dose combination tablet given once daily for 5 days on a 28-day cycle to IV decitabine (20mg/m2) administered as a daily 1-hour IV infusion for 5 days on a 28-day cycle, in the first 2 cycles. Patients continued to receive oral decitabine and cedazuridine from Cycle 3 onwards. The primary endpoint data for the study of total 5-day decitabine area-under-the-curve (AUC) equivalence of oral decitabine and cedazuridine and IV decitabine was previously presented at the American Society of Hematology Annual Meeting in December 2019.1 The oral/IV decitabine 5-day AUC was 98.9% with a 90% Confidence Interval between 92.7% and 105.6%.

Safety findings from the study were similar to those anticipated with IV decitabine, with incidence of cytopenias slightly higher with INQOVI during Cycle 1 compared to IV decitabine. The most common adverse events (AEs) of thrombocytopenia, neutropenia, and anemia were consistent with expected AEs with parenteral hypomethylating agent treatment.

In the more mature data set used to evaluate overall survival, the complete response (CR) rate for evaluable patients was 22%, with an overall response rate (CR + Partial Response + Marrow CR + Hematological Improvement) of 62%.

“Taken together, the ASCERTAIN phase 3 study data support considerable therapeutic utility of oral decitabine and cedazuridine in the treatment of patients with MDS and CMML,” said Co-Principal Investigator of the ASCERTAIN phase 3 study, Michael Savona, MD. “The fixed-dose combination of decitabine and cedazuridine is the only available oral DNA methyltransferase inhibitor / hypomethylating agent that has demonstrated equivalent exposure to an IV form. The median overall survival data from this study makes oral decitabine and cedazuridine an alternative option to parenteral administration of decitabine for patients with these diseases.”

Added Timothy Whitten, president and CEO of Taiho Oncology, Inc., Astex’s commercialization partner for INQOVI in the United States: “We are encouraged by data from the ASCERTAIN trial that continue to show oral decitabine and cedazuridine is a promising treatment option for patients living with MDS and CMML. Importantly, patients can benefit from the convenience of an at-home hypomethylating agent treatment and potentially reduce the number of office visits and associated travel.”

Based on the data from the ASCERTAIN clinical program, INQOVI is being investigated in combination with other agents in hematological malignancies, according to Harold Keer, MD, PhD, chief medical officer of Astex Pharmaceuticals, Inc. “The first of these studies is investigating the all-oral combination of decitabine and cedazuridine with venetoclax for the treatment of AML. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who have contributed to the clinical development program of oral decitabine and cedazuridine.”

INQOVI is an orally administered, fixed-dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine,2 an inhibitor of cytidine deaminase.3 By inhibiting cytidine deaminase in the gut and the liver, INQOVI is designed to allow for oral delivery of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine. The phase 1 and phase 2 clinical study results have been published in Lancet Haematology4 and Blood,5 respectively.

INQOVI was approved in July 2020 by the U.S. Food and Drug Administration (FDA) and by Health Canada. INQOVI is the first and only oral hypomethylating agent approved by the FDA and by Health Canada for the treatment of adults with intermediate and high-risk MDS including CMML.6

Commercialization of INQOVI in the U.S. and Canada is conducted by Taiho Oncology, Inc. and Taiho Pharma Canada, Inc., respectively. Astex, Otsuka and Taiho are all members of the Otsuka group of companies.

The presentation can be downloaded from the Astex website at: https://astx.com/ASTX727 – International MDS Symposium September 2021

Learn more about INQOVI at https://www.inqovi.com

INDICATIONS

INQOVI (decitabine and cedazuridine) is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.6

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Myelosuppression: Fatal and serious myelosuppression can occur with INQOVI. Based on laboratory values, new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%. Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3 or 4 occurring in 32%. Myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) is the most frequent cause of INQOVI dose reduction or interruption, occurring in 36% of patients. Permanent discontinuation due to myelosuppression (febrile neutropenia) occurred in 1% of patients. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS.

Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients, with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%. Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%.

Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors, and anti‑infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.

Embryo-Fetal Toxicity: INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise patients to use effective contraception during treatment with INQOVI and for 6 months (females) or 3 months (males) after last dose.

ADVERSE REACTIONS

Serious adverse reactions in > 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.

The most common adverse reactions (≥ 20%) were fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (>50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased.

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with INQOVI and for at least 2 weeks after the last dose.

Renal Impairment: No dosage modification of INQOVI is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr <15 mL/min).

Please see the accompanying Full Prescribing Information.

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.7,8 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.9 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.10 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML.

CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the U.S. is approximately 1,100 new cases per year,11 and CMML may transform into AML in 15% to 30% of patients.12

About Astex, Taiho, and Otsuka

Astex Pharmaceuticals, Inc. (“Astex”) is committed to the fight against cancer. Astex is developing a proprietary pipeline of novel therapies for the treatment of solid tumors and hematological malignancies. Astex is a member of the Otsuka group of pharmaceutical companies. The group also includes Otsuka Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. Subject to regulatory approvals, Astex’s products will be commercialized in the U.S. and Canada by Taiho subsidiaries, and in the rest of the world by Otsuka subsidiaries.

The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development of orally administered anti-cancer agents and markets these medicines for a range of tumor types in the U.S. Taiho Oncology’s growing pipeline of antimetabolic and selectively targeted anti-cancer agents are led by a world-class clinical development organization. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Zug, Switzerland and Oakville, Ontario, Canada.

Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, Inc. please visit: https://www.astx.com

For more information about Otsuka Pharmaceutical, please visit: https://www.otsuka.co.jp/en/

For more information about Taiho Oncology, please visit: https://www.taihooncology.com/

References

  1. Garcia-Manero G, McCloskey J, Griffiths EA, et al. Pharmacokinetic exposure equivalence and preliminary efficacy and safety from a randomized cross over Phase 3 study (ASCERTAIN study) of an oral hypomethylating agent ASTX727 (cedazuridine/decitabine) compared to IV decitabine. Blood. 2019; 134(Supplement_1).
  2. Oganesian A, Redkar S, Taverna P, Choy G, Joshi-Hangal R, Azab M. Preclinical data in cynomolgus (cyn) monkeys of ASTX727, a novel oral hypomethylating agent (HMA) composed of low-dose oral decitabine combined with a novel cytidine deaminase inhibitor (CDAi) E7727 [ASH Abstract]. Blood. 2013; 122(21): Abstract 2526.
  3. Ferraris D, Duvall B, Delahanty G, Mistry B, Alt, J, Rojas C, et al. Design, synthesis, and pharmacological evaluation of fluorinated tetrahydrouridine derivatives as inhibitors of cytidine deaminase. J Med Chem. 2014; 57: 2582-2588.
  4. Savona MR, Odenike O, Amrein PC, Steensma DP, DeZern AE, Michaelis LC, et al. An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study. Lancet Haematol [Internet]. 2019; 6(4): e194-e203.
  5. Garcia-Manero G, Griffiths EA, Steensma DP, et al. Oral cedazuridine/decitabine: a phase 2, pharmacokinetic/pharmacodynamic, randomized, crossover study in MDS and CMML [published online ahead of print, 2020 Apr 13]. Blood. 2020; blood.2019004143. doi:10.1182/blood.2019004143.
  6. INQOVI Prescribing Information. www.inqovi.com/pi
  7. Garcia-Manero G. Myelodysplastic syndromes: 2015 update on diagnosis, risk-stratification and management. Am J Hematol. 2015; 90(9): 831-841.
  8. Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: Incidence and survival in the United States. Cancer. 2007; 109(8): 1536–1542.
  9. Cogle C. Incidence and burden of the myelodysplastic syndromes. Curr Hematol Malig Rep. 2015; 10(3): 272-281.
  10. Shukron O, Vainstein V, Kündgen A, Germing U, Agur Z. Analyzing transformation of myelodysplastic syndrome to secondary acute myeloid leukemia using a large patient database. Am J Hematol. 2012; 87: 853–860.
  11. What are the key statistics about chronic myelomonocytic leukemia? American Cancer Society Web site. https://www.cancer.org/cancer/chronic-myelomonocytic-leukemia/about/key-statistics.html. Accessed 03 August 2021.
  12. About chronic myelomonocytic leukemia (CMML). Cancer Research UK Web site. https://www.cancerresearchuk.org/about-cancer/other-conditions/chronic-myelomonocytic-leukaemia-cmml/about. Accessed 03 August 2021.

INQ-PM-US-0362 09/21

Contacts

Martin Buckland

President & Chief Corporate Officer

Astex Pharmaceuticals, Inc.

4420 Rosewood Drive, Suite 200

Pleasanton, CA 94588, USA

Tel: +1-925-560-0100

Email: info@astx.com

Fulgent Genetics to Partner with Houston Health Department and Houston-Area Public Schools on Back-to-School COVID-19 Testing Program

Fulgent Genetics to Partner with Houston Health Department and Houston-Area Public Schools on Back-to-School COVID-19 Testing Program




Fulgent Genetics to Partner with Houston Health Department and Houston-Area Public Schools on Back-to-School COVID-19 Testing Program

TEMPLE CITY, Calif.–(BUSINESS WIRE)–$FLGT–Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, today announced that it will be partnering with the Houston Health Department and Houston-area public schools to provide COVID-19 testing to students during the current school year.

Fulgent will be providing RT-PCR testing to students whose parents consent for testing. Students are being statistically selected weekly across school districts in the Houston-area public school system, a process that will continue for the duration of the school year. Participating school districts include Houston ISD and Aldine ISD, the seventh largest and 54th largest school districts in the United States, respectfully. Fulgent is uniquely positioned to serve these districts with our CAP/CLIA certified laboratory located in Houston, Texas. Student samples will be delivered to the laboratory daily, and results will be available before the next school day.

“We are pleased to be partnering with the Houston Health Department and Houston-area public schools on their COVID-19 testing program for the school year,” said Brandon Perthuis, Chief Commercial Officer of Fulgent Genetics. “With COVID-19 cases on the rise across the country, we hope to help protect students and faculty from the spread of the virus, particularly as vaccination rates remain low with school-age children. Our ability to deliver high quality RT-PCR testing with differentiated service and rapid turnaround time remains a key reason why schools, hospitals and municipalities choose Fulgent as a trusted partner for COVID-19 testing.”

About Fulgent Genetics

Fulgent Genetics is a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health. Fulgent’s proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy, and competitive turnaround times. Combining next generation sequencing (“NGS”) with its technology platform, the Company performs full-gene sequencing with deletion/duplication analysis in an array of panels that can be tailored to meet specific customer needs. A cornerstone of the Company’s business is its ability to provide expansive options and flexibility for all clients’ unique testing needs through a comprehensive technology offering including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated lab services.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: Fulgent’s testing solutions and services, including its laboratory capacity and related matters; the Company’s identification and evaluation of opportunities, estimates of market size and its ability to capitalize on opportunities to grow its business.

Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the Company’s future performance, and they are based on management’s current assumptions, expectations and beliefs concerning future developments and their potential effect on the Company’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its genetics tests and the pandemic’s effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the Company’s tests, including its newly-developed tests for COVID-19 and genetic testing generally; the Company’s ability to capture a sizable share of the developing market for genetic and COVID-19 testing and to compete successfully in these markets, including its ability to continue to develop new tests that are attractive to its various customer markets, its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the Company’s ability to successfully integrate acquired businesses and assets into its business strategy and to derive value from its investments; the Company’s ability to maintain the low internal costs of its business model, particularly as the Company makes investments across its business; the Company’s ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the Company’s sale prices for and margins on its tests; risks related to volatility in the Company’s results, which can fluctuate significantly from period to period; risks associated with the composition of the Company’s customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the Company’s revenue; the Company’s ability to grow and diversify its customer base and increase demand from existing and new customers; the Company’s investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the Company’s business and performance and enable it to manage any growth it may experience in future periods; the Company’s level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the Company’s level of success in establishing and obtaining the intended benefits from CSI, partnerships, joint ventures or other relationships; the Company’s compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the Company’s international operations; the Company’s ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.

The forward-looking statements made in this press release speak only as of the date of this press release, and the Company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.

The Company’s reports filed with the U.S. Securities and Exchange Commission (“SEC”), including its annual report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 8, 2021 and the other reports it files from time to time, including subsequently filed quarterly and current reports, are made available on the Company’s website upon their filing with the SEC. These reports contain more information about the Company, its business and the risks affecting its business.

Contacts

The Blueshirt Group

Nicole Borsje, 415-217-2633; nicole@blueshirtgroup.com