Market Newsdesk

– Findings support upcoming launch of T-Detect
™
COVID
,
first
T-
cell
test for novel coronavirus

– Data support mounting evidence that
measuring
T-
cell
s
is
necessary
to
fully
characteriz
e
immune responses
to SARS-CoV-2
across the population

– Additional
supporting
data
to be
published
soon

SEATTLE, Nov. 13, 2020 (GLOBE NEWSWIRE) — Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that its T-Detect™ Assay for past SARS-CoV-2 infection in development identified 97% (68/70) of past PCR-confirmed SARS-CoV-2 infections compared to 77% (54/70) with commercial EUA approved antibody testing at similar specificity approximately two months after PCR diagnosis. Additionally, the T-cell response was greater in symptomatic versus asymptomatic subjects, whereas there was no correlation between antibody levels and disease severity in recovered patients. Preliminary results of this study, performed in collaboration with University of Padua and Ospedale San Raffaele in Milan, who were funded by a grant from Umberto Veronesi Foundation were made available on medRxiv. T-Detect™ COVID will be launched later this fall, becoming the first clinical T-cell based diagnostic test able to confirm past infections to SARS-CoV-2.

It is likely that some people may never develop antibodies to SARS-CoV-2 because they can resolve the infection early and effectively with T cells. Recent studies have demonstrated that antibodies appear to wane over time¹, while virus-specific T cells have been shown to persist for at least six months². This new study adds to mounting evidence that T cells, along with antibodies, may serve as an important correlate of immune protection and can help provide a more complete picture of the duration of immunity to the virus following an infection or administration of a vaccine.

“These data add to the growing body of real-world evidence that the T cell plays a critical role in immunity to SARS-CoV-2,” said Lance Baldo, Chief Medical Officer of Adaptive Biotechnologies. “T cells are emerging as another key indicator for past infection and immunity to the novel coronavirus, and a T-cell test for patients that is accurate and reproducible can serve large populations of people given what we are learning about the biology of the immune response.”

An initial study published in Nature in June 2020 was conducted by the University of Padua in which nearly the entire population of Vo’, Italy (2,900 of the town’s 3,275 residents), was tested using PCR for SARS-CoV-2 infection at the beginning and end of a 14-day lockdown of the town, followed by longer-term clinical monitoring. At that time, 81 people in the town tested positive for the virus in at least one of the two surveys. Interestingly, more than 40% of those who tested positive were asymptomatic, guiding the town’s response to the then-emerging pandemic and driving their success in containment³.

In a follow-up study of 2,290 residents, including 70 of the 81 who tested positive by PCR, antibody testing with a EUA approved commercial test (IgG) and T-cell testing with Adaptive’s T-Detect Assay for past SARS-CoV-2 infection were performed approximately 60 days after PCR testing. The T-cell assay identified 97% (68/70) of past PCR-confirmed SARS-CoV-2 infections compared to 77% (54/70) with the antibody test. Notably, 24 of the 70 PCR -positive patients were asymptomatic, highlighting the added sensitivity of T-cell based testing to provide a more accurate representation of past infection in a community. The T-cell response was measured by the overall quantity of T cells as well as the number of unique virus-specific T cells. Convalescent subjects who were symptomatic and hospitalized with COVID-19 had significantly greater T-cell response than asymptomatic subjects, while antibody levels did not correlate with disease severity.

Notably, an additional 45 (2.0%) of PCR-negative participants tested positive with the T-Detect Assay for past SARS-CoV-2 infection. About half of these individuals had reported symptoms before or after PCR testing or a household exposure, indicating the T-cell assay may also identify past infections that had been missed by prior PCR testing.

About T-Detect
™

T-Detect™ is a highly sensitive and specific diagnostic test under development for multiple diseases, translating the natural diagnostic capability of T cells into clinical practice. In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect COVID will be the first clinical test launched from this collaboration and the first commercially available T cell test designed to detect past SARS-CoV-2 infections. It is expected to launch this fall.

About Adaptive
Biotechnologies

Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics and drug discovery. We have two commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. For more information, please visit adaptivebiotech.com and follow us on www.twitter.com/adaptivebiotech.

Forward Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements.

These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including statements regarding T-Detect™ and its launch, potential commercial acceptance, or clinical utility, either with respect to COVID-19 or other disease states. These risks, uncertainties and other factors are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time, including a Quarterly Report on Form 10-Q to be filed later today. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

ADAPTIVE MEDIA

Beth Keshishian
917-912-7195
[email protected]

ADAPTIVE INVESTORS

Karina Calzadilla, Vice President, Investor Relations
201-396-1687
Carrie Mendivil, Gilmartin Group
[email protected]

^{___________________________________}
¹ Ward, et al.medRxiV preprint, 2020 
² Zuo, et al. bioRxiV preprint, 2020
³ Lavezzo, et al. Nature, 2020​

Investors with losses of more than $1,000,000 are encouraged to contact the firm before November 23, 2020; click 


here


to submit trade information

​LOS ANGELES, Nov. 13, 2020 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of Wrap Technologies, Inc. (NASDAQ: WRTC) investors that acquired shares between July 31, 2020 and September 23, 2020. Investors have until November 23, 2020 to seek an active role in this litigation.

Investors are encouraged to contact attorney Lesley F. Portnoy, to determine eligibility to participate in this action, by phone 310-692-8883 or email, or click here to join the case.

It is alleged in this lawsuit that, throughout the class period, defendants made misleading and/or false statements and/or failed to disclose that: (1) Wrap had concealed the results of the LAPD BolaWrap pilot program, which had demonstrated that the BolaWrap was expensive, sparingly used in the field, and ineffective; and (2) Wrap’s public statements were materially false and/or misleading at all relevant times, as a result. The lawsuit claims that investors suffered damages when the true details entered the market.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 23, 2020.

Please visit our website to review more information and submit your transaction information.

The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.

Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
[email protected]
310-692-8883
www.portnoylaw.com

Attorney Advertising

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that management will be participating in two upcoming virtual investor conferences and invites investors to participate by webcast. Please see additional details below:

• Jefferies 2020 Virtual London Healthcare Conference, November 17-19,2020
  Management will deliver a company presentation on Thursday, November 19 at 10:50 a.m. ET (3:50 p.m. GMT) and will also be available for one-on-one meetings. A live and archived webcast of the presentation will be available on the Investors section of the Aligos website: https://investor.aligos.com

• Piper Sandler 32
  
  ^nd
  
   Annual Virtual Healthcare Conference, December 1-3, 2020
  Management will present in a fireside chat format and will be available for one-on-one meetings. The presentations will be available prior to the dates of the conference. A replay of the fireside chat will be available in the Investors section of the Aligos website: https://investor.aligos.com

About Aligos

Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements.” Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Aligos’s clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’s prospectus filed with the Securities and Exchange Commission on October 19, 2020, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
[email protected]

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
[email protected]

FALLS CHURCH, Va., Nov. 13, 2020 (GLOBE NEWSWIRE) — PAE (NASDAQ: PAE, PAEWW), a global leader in delivering smart solutions to the U.S. government and its allies, was awarded a position on the U.S. Air Force Rotary Wing Maintenance Contract Consolidation indefinite delivery, indefinite quantity contract vehicle, which has a ceiling value of $835 million and a 10-year period of performance. The Air Force Installation Contracting Center also awarded PAE an initial five-year task order on the contract, valued at $84.3 million, to support helicopter maintenance for training missions with the Air Education and Training Command at Kirtland Air Force Base in Albuquerque, New Mexico.

The awards build on PAE’s nearly four decades of aviation support for U.S. government customers, including four branches of the military and the Department of Homeland Security. PAE President and CEO John Heller said this work supporting critical Air Force missions contributes to a business strategy of delivering world class aerospace services through innovation and technology integration.

“PAE’s specialized fleet management expertise is a clear advantage to winning key Air Force support work, strengthened by our certified continuous improvement practices,” Heller said. “Not only does our position on this IDIQ expand our reach with the Air Force, but it brings the potential to apply our rotary wing capabilities to the latest technologies, including the newly acquired MH-139 helicopter.”

PAE is one of five large business contractors awarded a seat on the contract vehicle that also includes three small business awardees. The program consolidates Air Force helicopter programs for the full-time availability of mission-capable aircraft, including UH-1N and HH-60 helicopters and V-22 tilt-rotor aircraft. The scope of the contract includes functional check flights, aircrew flight equipment and the maintenance of light caliber weapons and defensive systems.

PAE Vice President of Readiness and Sustainment Cristal Rice said PAE will deliver mission-essential services on the initial task order for the Air Force’s premier training site for special operations, combat search and rescue aircrews.

“We’re proud to continue our work with the AETC program to provide safe and high-quality aircraft maintenance,” said Rice. “Our services are critical to student pilots as they’re trained on a wide range of flight specialties in aircraft that we maintain for the 58^th Special Operations Wing.”

PAE serves as the prime contractor on the task order, with support from subcontractors CLX Support Services and VP KIRA, to deliver personnel to maintain, repair and functionally check helicopters and associated engines, as well as provide mission support equipment, technical support and aircrew services in support of flight crew training missions at Kirtland Air Force Base.

About PAE

For 65 years, PAE has tackled the world’s toughest challenges to deliver agile and steadfast solutions to the U.S. government and its allies. With a global workforce of about 20,000 on all seven continents and in approximately 60 countries, PAE delivers a broad range of operational support services to meet the critical needs of our clients. Our headquarters is in Falls Church, Virginia. Find us online at pae.com, on Facebook, Twitter and LinkedIn.

Forward-Looking Statements

This release may contain a number of “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about PAE’s possible or assumed future results of operations, financial results, backlog, estimation of resources for contracts, strategy for and management of growth, needs for additional capital, risks related to U.S. government contracting generally, including congressional approval of appropriations, bid protests and IDIQs. These forward-looking statements are based on PAE’s management’s current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events.

These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside PAE’s management’s control, that could cause actual results to differ materially from the results discussed in the forward-looking statements.

Forward-looking statements included in this release speak only as of the date of this release. PAE does not undertake any obligation to update its forward-looking statements to reflect events or circumstances after the date of this release except as may be required by the federal securities laws.

For media inquiries regarding PAE, contact:

Terrence Nowlin
Senior Communications Manager
PAE
703-656-7423
[email protected]

For investor inquiries regarding PAE, contact:

Mark Zindler
Vice President, Investor Relations
PAE
703-717-6017
[email protected]

 

THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES.

HAMILTON, Ontario, Nov. 13, 2020 (GLOBE NEWSWIRE) — Reliq Health Technologies Inc. (TSXV:RHT or OTCQB:RQHTF) (“Reliq” or the “Company”), a technology company focused on developing innovative mobile health (mHealth) and telemedicine solutions for Community-Based Healthcare, is pleased to announce that it has closed the first tranche of its private placement announced October 27, 2020. The Company issued 10,637,056 units (the “Units”) at a price of $0.225 per unit for gross proceeds of $2,393,337.60 for the first tranche.

Due to exceptional demand, the Company intends to close a second tranche, with final closing taking place on or before December 7, 2020. Pursuant to a price reservation form 4A filed with the TSX-V Venture Exchange on October 22, 2020, the Company may offer up to an additional 2,696,277 Units in a second tranche.

Each Unit will consist of one (1) common share and one-half (1/2) of a share purchase warrant (each whole warrant, a “Warrant”). Each Warrant will be exercisable for an additional share at a price of $0.30 for a period of two (2) years from issuance. In the event that the common shares of the Company trade at a closing price of greater than $0.50 per Share for ten (10) consecutive trading days, the Company may accelerate the expiry date of the Warrants to expire on the 30th day after the date on which such notice is given to the warrantholders.

The Company is paying finder’s fees of $44,431.88 cash and 188,775 broker warrants in connection with the first tranche. The broker warrants are issued with the same terms as the Warrants described above.

The Company’s CEO participated in the first tranche of the Offering and will acquire an aggregate of 444,500 Units. The participation by insiders in the Offering is considered to be a “related party transaction” as defined under Multilateral Instrument 61-101 (“MI 61- 101”). The transaction is exempt from the formal valuation and minority shareholder approval requirements of MI 61-101, as neither the fair market value of the securities being issued nor the consideration being paid exceeds 25% of the Company’s market capitalization.

The Company intends to use the net proceeds to support onboarding of new clients. All securities issued pursuant to the offering will be subject to a statutory hold period of four months plus a day from issuance in accordance with applicable securities laws. Closing of the Offering is subject to receipt of all necessary regulatory approvals and final acceptance by the TSX Venture Exchange.

About Reliq Health
Reliq Health Technologies is a healthcare technology company that specializes in developing innovative software solutions for the Community Care market. Reliq’s powerful iUGO Care platform supports care coordination and community-based healthcare. iUGO Care allows complex patients to receive high quality care at home, improving health outcomes, enhancing quality of life for patients and families and reducing the cost of care delivery. iUGO Care provides real-time access to remote patient monitoring data, allowing for timely interventions by the care team to prevent costly hospital readmissions and ER visits. Reliq Health Technologies trades on the TSX Venture under the symbol RHT and on the OTCQB as RQHTF.

ON BEHALF OF THE BOARD

“Dr. Lisa Crossley”

CEO and Director

For further information please contact:

Investor Relations at [email protected]

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statements Regarding Forward Looking Information

Certain statements in this press release constitute forward-looking statements, within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements”.

We caution you that such “forward-looking statements” involve known and unknown risks and uncertainties that could cause actual and future events to differ materially from those anticipated in such statements.

Forward-looking statements include, but are not limited to, statements with respect to commercial operations, including technology development, anticipated revenues, projected size of market, and other information that is based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management.

Reliq Health Technologies Inc. (the “Company“) does not intend and does not assume any obligation, to update these forward-looking statements except as required by law. These forward-looking statements involve risks and uncertainties relating to, among other things, technology development and marketing activities, the Company’s historical experience with technology development, uninsured risks. Actual results may differ materially from those expressed or implied by such forward-looking statements.

SOURCE: Reliq Health Technologies Inc.

HAMILTON, Ontario, Nov. 13, 2020 (GLOBE NEWSWIRE) — Ackroo Inc. (TSX-V: AKR; OTC: AKRFF) (the “Company”), a loyalty marketing, payments and point-of-sale technology and services provider, has completed its previously announced private placement of 25,000,000 Units at a price of $0.12 per Unit for gross proceeds of $3,000,000. Each “Unit” consists of one common share of the Company and one share purchase warrant (each a “Warrant“) entitling the holder to purchase an additional common share of the Company at a price of $0.18 per share until November 12, 2023. The Warrants are subject to accelerated expiry in the event the closing price of the Company’s shares on or after 18 months from the date of closing is $0.28 or more for twenty consecutive trading days. The proceeds are from 4 different parties including Shen Capital Fund L.P. (“Shen Capital”), DKAM Capital Ideas Fund, Rivemont MicroCap Fund and a long-term shareholder of the Company representing a family fund.

In connection with the subscription from Shen Capital, the Company has agreed to grant Shen Capital the right to nominate one member to the Board of Directors, who shall initially be Francis Shen, and one board observer, who shall initially be Andrew Shen.

“We are excited to have this financing completed and the addition of Francis Shen to our board of directors,” said Steve Levely, CEO of Ackroo. “As we continue to execute on our vision to consolidate, simplify and improve the merchant marketing, payments and point-of-sale ecosystem, having both a financial sponsor and business advisors to assist us is critical. Francis and Shen Capital will help play a key role in guiding our success. We are excited to have key shareholders participate, including DKAM Capital Ideas Fund, led by director Jason Donville. We are eager to drive great returns for our investor base and are excited for what lies ahead.”

No finders’ fees were paid in connection with the private placement. All securities issued in the private placement are subject to a four month and a day hold period until March 13, 2021.

About Ackroo

Through vendor and industry consolidation, Ackroo provides merchants of all sizes a data driven cloud based multi-currency marketing platform to help attract, engage and grow their customers while increasing their revenues and margins. Via a SaaS based business model Ackroo provides an in-store and online automated solution to help merchants process loyalty, gift card and promotional transactions at the point of sale, provide key administrative and marketing data, and to allow customers to access and manage their loyalty and gift card accounts. Ackroo also provides important marketing, payment and point-of-sale solutions as an extension of the Ackroo platform to drive even greater financial and operational results for their clients. Ackroo is headquartered in Hamilton, Ontario, Canada. For more information, visit: www.ackroo.com.

For further information, please contact:

Steve Levely Chief Executive Officer | Ackroo Tel: 416-360-5619 x730 Email: [email protected]

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

Forward Looking Statements

This release contains forecasts and forward-looking statements that are not guarantees of future performance and activities and are subject to risks and uncertainties. The Company has based these forward-looking statements on assumptions and assessments made by its management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, but are not limited to: the Company’s ability to raise enough capital to support the Company’s go forward plans; the overall global economic environment; the impact of competition and new technologies; general market, political and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; changes in the Company’s strategy; government regulations and approvals; changes in customers’ budgeting priorities; plus other factors that may arise. Any forward-looking statements in this press release are made as of the date hereof, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investors with losses are encouraged to contact the firm before November 20, 2020; click


here


to submit trade information

LOS ANGELES, Nov. 13, 2020 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of Fluidigm Corporation (NASDAQ: FLDM) investors that acquired shares between February 17, 2019 and November 5, 2019. Investors have until November 20, 2020 to seek an active role in this litigation.

Investors are encouraged to contact attorney Lesley F. Portnoy, to determine eligibility to participate in this action, by phone 310-692-8883 or email, or click here to join the case.

Fluidigm reported second quarter 2019 financial results in a press release issued on August 2, 2019. It was disclosed in this press release that Fluidigm reported revenue of $28.2 million, which is below analysts’ estimate of $32 million, and a net loss of $13.8 million.

Fluidigm’s share price fell $4.10, or 34%, to close at $8.05 per share on August 2, 2019, on this news, thereby injuring investors.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 20, 2020.

Please visit our website to review more information and submit your transaction information.

The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.

Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
[email protected]
310-692-8883
www.portnoylaw.com

Attorney Advertising

• U.S. Food and Drug Administration
  (FDA)
  clear
  ance
  of
  PMV
  Pharmaceutical
  ’s investigational new drug
  application for its lead product candidate
  PC14586
• PMV Pharma lead product candidat
  e
  PC14586 granted Fast Track designation by the
  FDA
• Expanded Board of Directors with appointment of
  Rich Heyman, Ph.D
  .
  ,
  and Laurie
  Stelzer
• Suc
  cessful completion of initial public offering, raising approximately $243.5 million.

CRANBURY, N.J., Nov. 13, 2020 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today reported financial results for the third quarter ended September 30, 2020, and provided corporate highlights.

“PMV Pharma has achieved important scientific, clinical, and operational milestones over the past quarter,” said David Mack, Ph.D., President and Chief Executive Officer. “The Investigational New Drug (IND) application for our lead product candidate PC14586 was cleared by the U.S. FDA in September. We believe the capital raised to date will enable us to execute on the clinical development of PC14586, while also continuing to invest in our discovery pipeline of small molecule, tumor-agnostic precision medicine products.”

Corporate Highlights

• Received IND clearance from the FDA to initiate a Phase 1/2 study of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. The Phase 1/2 study will enroll patients with a p53 Y220C mutation as determined by next generation sequencing. Phase 1 will evaluate escalating doses of PC14586 to determine the recommended Phase 2 dose and to assess safety, pharmacokinetics, and preliminary anti-tumor activity. Phase 2 will determine the overall response rate and duration of response. For more information, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).
• In October, the U.S. FDA granted PMV Pharma Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
• Expanded PMV Pharma’s management team and Board of Directors by adding Robert Ticktin as General Counsel, along with Rich Heyman, Ph.D. as Chair of the Board of Directors, and Laurie Stelzer, as Audit Chair of the Board of Directors.
• Advanced its R273H program, targeting a second p53 hot spot mutant, toward lead optimization, and progressed the Company’s pipeline derived from its proprietary discovery platform.
• Raised $70.0 million in a Series D financing round in July 2020 with Avoro Capital, RA Capital Management, and Wellington Management Company joining existing investors OrbiMed Advisors, Nextech Invest, Viking Global Investors, and Boxer Capital of Tavistock Group.
• Successfully completed an IPO at a public offering price of $18 per share, with gross proceeds totaling approximately $243.5 million.

Third Quarter 2020
Financial Highlights

• PMV Pharma ended the third quarter with $373.1 million in cash, cash equivalents, and marketable securities compared to $101.5 million as of December 31, 2019. Net cash provided by financing activities for the nine months ended September 30, 2020 was $294.3 million compared to $0.1 million for the nine months ended September 30, 2019. Net cash used in operations was $22.4 million for the nine months ended September 30, 2020 compared to $17.0 million for the nine months ended September 30, 2019.
• Net loss for the quarter ended September 30, 2020 was $8.8 million compared to $6.2 million for the quarter ended September 30, 2019.
• Research and development (R&D) expenses were $6.0 million for the quarter ended September 30, 2020 compared to $4.9 million for the quarter ended September 30, 2019. The increase in R&D expenses was primarily related to increase in personnel, preclinical development, and IND filing of PC14586.
• General and administrative (G&A) expenses were $2.7 million for the quarter ended September 30, 2020, compared to $1.5 million for the quarter ended September 30, 2019. The increase in G&A expenses was primarily due to an increase in personnel and other corporate costs related to building out infrastructure for growth.

About
PMV Pharma

PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus.  PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.

Forward-Looking
Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s future plans or expectations for PC14586, including expectations regarding the success of its current clinical trial for PC14586; the future plans or expectations for the Company’s discovery platform, including the advancement of our R273H program to lead optimization; and the period over which the Company estimates its existing cash and cash equivalents will be sufficient to fund its current operating plan. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities and planned clinical trials, the Company’s ability to execute on its strategy, regulatory developments in the United States and operate as an early clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company’s ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 13, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

PMV Pharmaceuticals
, Inc.

Condensed Consolidated Balance Sheet Data

(Unaudited)

(in thousands)

		September 30, 2020 (unaudited)				December 31, 2019
Assets
Current assets
Cash and cash equivalents		$	373,150			$	73,278
Short-term marketable securities			—				28,208
Prepaid expenses and other current assets			522				607
Total current assets			373,672				102,093
Property and equipment, net			573				739
Other assets			201				201
Total assets		$	374,446			$	103,033
Liabilities, Convertible Preferred Stock, and Stockholders’ Equity (Deficit)
Current liabilities
Accounts payable		$	548			$	2,837
Accrued expenses			4,928				1,686
Total current liabilities			5,476				4,523
Other liabilities			—				51
Total liabilities			5,476				4,574
Convertible preferred stock			—				168,933
Stockholders’ equity (deficit):
Preferred stock			—				—
Common stock			—				—
Additional paid-in capital			468,396				4,969
Accumulated deficit			(99,426	)			(75,440	)
Accumulated other comprehensive loss			—				(3	)
Total stockholders’ equity (deficit)			368,970				(70,474	)
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)		$	374,446			$	103,033

PMV Pharmaceuticals, Inc.

Condensed Statements of Opera
tions and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Operating Expenses:
Research and development		$	5,992			$	4,895			$	17,752			$	15,060
General and administrative			2,709				1,545				6,689				4,222
Total operating expenses			8,701				6,440				24,441				19,282
Loss from operations			(8,701	)			(6,440	)			(24,441	)			(19,282	)
Other (expense) income
Interest income, net			40				272				603				985
Other expense:			(100	)			—				(143	)			—
Total other (expense) income			(60	)			272				460				985
Loss before provision for income taxes			(8,761	)			(6,168	)			(23,981	)			(18,297	)
Provision for income taxes			3				7				5				8
Net loss			(8,764	)			(6,175	)			(23,986	)			(18,305	)
Unrealized (loss) gains on marketable securities, net of tax			(5	)			(2	)			3				14
Comprehensive loss		$	(8,769	)		$	(6,177	)		$	(23,983	)		$	(18,291	)
Net loss per share — basic and diluted		$	(1.46	)		$	(2.03	)		$	(5.93	)		$	(6.04	)
Weighted-average common shares outstanding			6,022,457				3,046,200				4,045,527				3,031,416

Contact

For Investors:

Winston Kung
Chief Financial Officer
[email protected]

For Media:

Mariann Caprino
[email protected]
(917) 242-1087 mobile

Investors with losses are encouraged to contact the firm before December 14, 2020; click


here


to submit trade information

LOS ANGELES, Nov. 13, 2020 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of Loop Industries, Inc. (NASDAQ: LOOP) investors that acquired shares between September 24, 2018 and October 12, 2020. Investors have until December 14, 2020 to seek an active role in this litigation.

Investors are encouraged to contact attorney Lesley F. Portnoy, to determine eligibility to participate in this action, by phone 310-692-8883 or email, or click here to join the case.

The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Loop is the subject of a report issued by Hindenburg Research on October 13, 2020. The report, titled “Loop Industries: Former Employees and Plastics Experts Blow The Whistle On This ‘Recycled’ Smoke And Mirrors Show,” alleges that “a former Loop employee told us that Loop’s scientists, under pressure from CEO Daniel Solomita, were tacitly encouraged to lie about the results of the company’s process internally. We have obtained internal documents and photographs to support their claims.” Hindenburg writes that “according to a former employee, Loop’s previous claims of breaking PET down to its base chemicals at a recovery rate of 100% were ‘technically and industrially impossible.'” The report also alleges that “Executives from a division of key partner Thyssenkrupp, who Loop entered into a ‘global alliance agreement’ with in December 2018, told us their partnership is on ‘indefinite’ hold and that Loop ‘underestimated’ both costs and complexities of its process.” Based on this report, shares of Loop fell by more than 31% in intraday trading.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than December 14, 2020.

Please visit our website to review more information and submit your transaction information.

The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.

Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
[email protected]
310-692-8883
www.portnoylaw.com

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Investors with losses are encouraged to contact the firm before January 4, 2021; click


here


to submit trade information

LOS ANGELES, Nov. 13, 2020 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) investors that acquired shares between September 28, 2019 and October 7, 2020. Investors have until January 4, 2021 to seek an active role in this litigation.

Investors are encouraged to contact attorney Lesley F. Portnoy, to determine eligibility to participate in this action, by phone 310-692-8883 or email, or click here to join the case.

Intercept’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used for the treatment of a rare and chronic liver disease, primary biliary cholangitis (“PBC”), in combination with ursodeoxycholic acid in adults. Intercept is also developing OCA for various other indications, including nonalcoholic steatohepatitis (“NASH”).

In 2016, accelerated approval of Ocaliva for treating PBC was granted by the U.S. Food and Drug Administration (“FDA”).

Then, in late 2017, both the FDA and Intercept issued warnings concerning the risk of overdosing patients with the drug, including multiple reports of severe liver injuries and deaths linked with its use.

Defendants continued to tout Ocaliva sales and purported benefits, and its potential indication for treating various other medical conditions, despite these concerns. For example, in September 2019, Intercept submitted a New Drug Application (“NDA”) to the FDA for OCA to treat patients with liver fibrosis due to NASH.

It is alleged in the complaint that Intercept, throughout the Class Period, made materially misleading and false statements regarding their business, operational, and compliance policies. Specifically, Intercept made misleading and/or false statements and/or failed to disclose that: (i) Defendants downplayed the severity and true scope of safety concerns associated with Ocaliva’s use in treating PBC; (ii) the foregoing increased the likelihood of an investigation into Ocaliva’s development by the FDA, thereby jeopardizing Ocaliva’s the sustainability of its sales and continued marketability; (iii) the risks of its use outweighed any purported benefits associated with OCA’s efficacy in treating NASH; (iv) the FDA was unlikely to approve the Company’s NDA for OCA in treating patients with liver fibrosis due to NASH, as a result; and (v) Intercept’s public statements were materially misleading and false at all relevant times, as a result of all the foregoing.

Intercept reported on May 22, 2020 that the FDA “has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company’s [NDA] for [OCA] for the treatment of liver fibrosis due to [NASH] has been postponed” to “accommodate the review of additional data requested by the FDA that the company intends to submit within the next week.”

On May 22, 2020, Intercept’s stock price fell $11.18 per share, or 12.19%, to close at $80.51 per share on this news.

Intercept issued a press release on June 29, 2020 announcing that the FDA had issued a Complete Response Letter (“CRL”) rejecting the Company’s NDA for Ocaliva for the treatment of liver fibrosis due to NASH. According to that press release, “[t]he CRL indicated that, based on the data the FDA has reviewed to date,” the FDA “has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.” Among other things, it was further advised in this press release, that “[t]he FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.”

On June 29, 2020, Intercept’s stock price fell $30.79 per share, or 39.73%, to close at $46.70 per share on this news.

Then, on October 8, 2020, various news outlets reported that Intercept was “facing an investigation from the [FDA] over the potential risk of liver injury in patients taking Ocaliva, [Intercept’s] treatment for primary biliary cholangitis, a rare, chronic liver disease.”

On October 8, 2020, Intercept’s stock price fell $3.30 per share, or 8.05%, to close at $37.69 per share on this news.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than January 4, 2021.

Please visit our website to review more information and submit your transaction information.

The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.

Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
[email protected]
310-692-8883
www.portnoylaw.com

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