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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

Attorney Advertising

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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

Attorney Advertising

Novel
Base Edit
ors for
Two
Most Common
GSDIa
Mutations
Demonstrate Significantly Higher
Levels of
In Vivo
Mutation C
orrection
than Required to Restore Glucose H
omeostasis

Previously Presented Data from Alpha-1 Program
to be Reviewed in Encore Presentation

CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that the company will present preclinical data from its liver-focused programs, including the first data highlighting its novel base-editing strategy for correcting disease-causing mutations underlying Glycogen Storage Disease Type Ia (GSDIa), during the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting Digital Experience being held virtually November 13-16, 2020.

GSDIa, also known as Von Gierke disease, is an inborn disorder of glucose metabolism caused by mutations in the G6PC gene that disrupt a key enzyme, Glucose-6- Phosphatase (G6Pase), which is involved in glucose homeostasis. This disruption results in low blood glucose levels that can be fatal if patients do not adhere to a strict regimen of slow-release forms of glucose, administered every one to four hours (including overnight). There are currently no pharmacological therapies approved for patients with GSDIa. Beam has engineered novel adenine base editors (ABE) that, in preclinical models, have achieved high levels of precise correction of the two most prevalent GSD1a mutations, R83C and Q347X, in both in vitro and in vivo settings.

“Base editing represents an exciting new opportunity for the treatment of serious diseases, including GSDIa, where patients are in need of a disease-modifying, life-long treatment,” said Giuseppe Ciaramella, Ph.D., president and chief scientific officer of Beam. “These first preclinical data from our GSDIa program demonstrate significant levels of precise correction of the disease-causing R83C and Q347X point mutations, well above the level that we believe is needed to have a clinically relevant treatment effect for patients with GSD1a. We look forward to presenting these data, as well as our encore presentation of our Alpha-1 data from ASGCT, as we continue to advance our liver base editing programs toward the clinic.”

Details of the GSDIa presentation are as follows:

Title: Base-Editing as a Therapeutic Approach for the Direct Correction of Disease-Causing Mutations Underlying Glycogen Storage Disease Type Ia
Publication Number: 0589
Session Title: Genomics and Precision Medicine
Data Summary: Beam’s approach to treating patients with GSDIa is to deliver an ABE via lipid nanoparticle (LNP) to the liver to repair either the R83C or the Q347X mutations in G6PC. It is estimated that these two-point mutations account for 900 and 500 patients, respectively, in the United States, representing approximately 60% of all GSDIa patients. Animal studies suggest that a critical therapeutic threshold of approximately 11% of normal G6Pase activity in liver cells is sufficient to restore fasting glucose; however, this level must be maintained in order to preserve glucose control and alleviate other serious, and potentially fatal, GSDIa symptoms. In vivo correction of both mutations by ABEs was observed in the livers of two strains of transgenic mice, each carrying one of the two G6PC mutations. Next-generation sequencing data from whole liver extracts reveal significant correction for both R83C and Q347X, with nearly 40% and approximately 70% A-to-G conversion efficiency, respectively, of each mutation back to the normal gene sequence. These significant levels of mutation correction greatly surpass those expected to restore glucose homeostasis, and functional studies are ongoing to correlate pathophysiology to extent of mutation correction by base-editing. Further, these levels of in vivo correction for GSDIa by base-editing are achieved without creation of double-stranded breaks. In total, these data support base-editing technology as a promising approach for precise correction of causative mutations in GSDIa.

Beam will also report data during an oral presentation at AASLD from its Alpha-1 Antitrypsin Deficiency (Alpha-1) program, which were previously presented at American Society of Gene & Cell Therapy 2020 Annual Meeting. Details of the Alpha-1 presentation are as follows:

Title: Evaluation of Adenine Base Editing as a Potential Treatment for Alpha-1 Antitrypsin Deficiency
Publication Number: 0032
Session Title: Parallel 3: Metabolic and Genetic Diseases
Session Broadcast Date and Time: Saturday, November 14, 2020, 2:00 p.m. ET

About Beam Therapeutics

Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company developing precision genetic medicines through the use of base editing. Beam’s proprietary base editors create precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This enables a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. For more information, visit www.beamtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including, but not limited to, statements related to: our plans for scientific publications; our plans to advance our liver base editing programs toward the clinic; the expected levels of GSDIa mutation correction that are required to be clinically relevant and disease-modifying in humans; and the therapeutic applications and potential of our technology, including our ability to develop precision genetic medicines for patients through base editing. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including, without limitation, risks and uncertainties related to: our ability to develop, obtain regulatory approval for, and potentially commercialize our product candidates, which may take longer or cost more than planned; our ability to raise additional funding, which may not be available; our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates; the potential impact of the COVID-19 pandemic; that preclinical testing of our product candidates and preliminary or interim data from preclinical and clinical trials may not be predictive of the results or success of ongoing or later clinical trials; that enrollment of our clinical trials may take longer than expected; that our product candidates may experience manufacturing or supply interruptions or failures; risks related to competitive products; and the other risks and uncertainties identified under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30, 2020, and in any subsequent filings with the Securities and Exchange Commission. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

Contacts:

Investors:
Chelcie Lister
THRUST Strategic Communications
[email protected]

Media:
Dan Budwick
1AB
[email protected]

Investors with losses are encouraged to contact the firm before November 16, 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 Nikola Corporation (NASDAQ: NKLA) investors that acquired shares between March 3, 2020 and September 20, 2020. Investors have until November 16, 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.

On September 10, 2020, Hindenburg Research, an investment analyst, issued a report on Nikola Corporation entitled “Nikola: How to Parlay An Ocean of Lies Into a Partnership With the Largest Auto OEM in America[.]” It is alleged in the Hindenburg report that Nikola “is an intricate fraud built on dozens of lies . . .” It is also alleged in this report report, among other things, that Nikola claims to “design[] all key components in house, but they appear to simply be buying or licensing them from third-parties. . . . [W]e found that Nikola actually buys inverters from a company called Cascadia. In a video showing off its ‘in-house’ inverters, Nikola concealed the Cascadia label with a piece of masking tape.” It is further asserted by Hindenburg that investors were misled by Nikola with regard to its battery and hydrogen fuel cell claims, as well as its purported “multi-billion-dollar order book,” which Hindenburg asserts is “filled with fluff.”

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 16, 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

–
Data demonstrated
compelling efficacy
profile
and favorable tolerability with weekly and every two-week dosing –

–
C
onsistent results and baseline characteristics across biopsy
confirmed and phenotypic NASH patients
–

–
Positive, highly
significant c
orrelation between relative changes in
liver fat reduction
and ALT
–

SAN FRANCISCO, Nov. 13, 2020 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced updated data from its positive Phase 1b/2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). Previously disclosed topline data demonstrated reductions in liver fat with concurrent beneficial effects on lipids and other metabolic parameters, as well as favorable tolerability, with both weekly and every two-week dosing. New analyses from the trial will be presented today in a late-breaking poster (abstract #LP34) at The Liver Meeting Digital Experience™ 2020 of the American Association for the Study of Liver Diseases (AASLD).

“I believe that these data highlight BIO89-100’s robust potency in reducing liver fat as assessed by MRI-PDFF over a 12-week period. New analyses of the data demonstrate the strong and significant correlation between relative reductions in MRI-PDFF and serum ALT in patients treated with BIO89-100. Responses on these two measures have been shown to translate into histology improvement and potentially a clinically meaningful benefit in patients with NASH,” said Rohit Loomba, MD, MHSc, Director of the UC San Diego NAFLD Research Center and Director of Hepatology at UC San Diego School of Medicine. “We saw a remarkable consistency of results across the sub-populations of biopsy-confirmed NASH and phenotypic NASH (PNASH) patients enrolled in the trial. Baseline characteristics were similar across these sub-populations and BIO89-100 treatment resulted in similar reductions in liver fat, ALT, and triglycerides.”

“We are moving forward with a comprehensive clinical development program designed to build upon the promising results from BIO89-100’s Phase 1b/2a trial, which includes plans to initiate a Phase 2b study in the first half of 2021 and an open-label paired biopsy histology cohort in the near-term. Today’s data are encouraging for these planned studies as we believe they demonstrate BIO89-100’s compelling risk-benefit profile as a leading FGF21 analog in a class that could become a key part of the NASH treatment paradigm,” said Rohan Palekar, Chief Executive Officer, 89bio.

A copy of the poster presentation, entitled “BIO89-100 Demonstrated Robust Reductions in Liver MRI-PDFF, Favorable Tolerability and Potential for Every 2 Weeks Dosing in a Phase 1b/2a Placebo-Controlled, Double Blind, Multiple Ascending Dose Study in NASH,” is available on the AASLD website and is also available for download via the 89bio website.

The data presented show:

• Similar reductions in liver fat, ALT and triglycerides between biopsy-confirmed NASH and PNASH patients treated with BIO89-100 and, importantly, their similar baseline characteristics underscored the consistency across these two sub-populations of patients enrolled in the trial.
• Pharmacokinetics of BIO89-100 demonstrated dose proportional PK.
• Positive and highly significant correlation (r=0.540, p<0.001) between relative reduction in liver fat by MRI-PDFF and ALT reduction at Week 13.
• Treatment with BIO89-100 (N=81) resulted in significant reductions in liver fat on MRI-PDFF at Week 13 across all dose groups vs. placebo, with up to 70% and 60% relative reductions for the 27mg-QW and 36mg-Q2W dose groups vs. placebo, respectively (p<0.001).
• Significant proportion of patients responded to therapy with up to 88% and 71% of patients achieving a ≥30% and a ≥50% reduction in liver fat vs. baseline, respectively.
• Significant benefit in markers of liver injury and fibrosis, with up to 44% reduction in ALT and a 35 Units/Liter (U/L) decrease in patients with high ALT was observed.
• Significant improvements were also observed in triglycerides. Reductions in TGs was more pronounced in patients who had higher levels of TGs at baseline.
• Improvements were also noted across the spectrum of metabolic marker data vs. placebo for the 27mg QW dose group including HOMA-IR, glucose, HbA1c, weight (p<0.05) and adiponectin (p<0.001).
• BIO89-100 was well-tolerated across all doses with no deaths or serious adverse events related to treatment and a low incidence of treatment-related adverse events (TRAEs) that occurred in ≥ 10% of patients.
• Low frequency of gastrointestinal (GI) related adverse events was observed with a profile for BIO89-100 that was similar to placebo. Low rates of diarrhea (9.5% vs. 11.1% for placebo) and nausea (4.8% vs. 11.1% for placebo) and importantly, no vomiting were reported in BIO89-100 treated patients. No hypersensitivity AEs, few mild injection site reaction events, no tremor and no adverse effects on heart rate or blood pressure were observed.

About NASH        
NASH is the most advanced stage of nonalcoholic fatty liver disease (NAFLD). It is a complex metabolic disorder that causes fat buildup in the liver, as well as inflammation and eventually fibrosis, and it can worsen to cirrhosis and liver failure. NASH affects more than 16 million adults in the United States, and by 2030 its prevalence is predicted to increase by 63 percent. The exact cause of NASH is unknown, but it is commonly found in people with obesity and type 2 diabetes. While there are currently no approved treatments, the biopharmaceutical industry is actively involved in addressing this unmet medical need.

About the Phase 1b/2a Study        
This clinical study was a multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial. It was designed to assess the safety, tolerability, and PK properties of BIO89-100 as well as change in liver fat measured by MRI-PDFF and key biomarker assessments in patients with biopsy-proven NASH with fibrosis or patients with phenotypical NASH (PNASH). PNASH was defined as patients with steatosis greater than 10% who have central obesity and Type 2 diabetes or central obesity and evidence of liver injury. Both populations that were enrolled had similar disease characteristics at baseline. A total of 81 patients were randomized to receive weekly or every two weeks subcutaneous dosing of BIO89-100 or placebo for up to 12 weeks. Results observed across all dose groups from the trial add to a growing body of evidence demonstrating the promise of BIO89-100 for the treatment of NASH. Results showed robust reductions in liver fat and key liver markers. A strong efficacy profile and favorable tolerability were observed with weekly and every two-week dosing.

About BIO89-100        
BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH. 89bio has optimally engineered BIO89-100 using a proprietary glycoPEGylation technology to balance efficacy and longer dosing interval. Recent Phase 1b/2a data show BIO89-100 demonstrated a favorable safety and tolerability profile and robust reductions in liver fat and key lipid markers when dosed weekly (QW) or once every two weeks (Q2W). BIO89-100 is also being developed for the treatment of severe hypertriglyceridemia (SHTG) and is currently in a Phase 2 trial.

About 89bio

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, BIO89-100, is a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel.

Forward-looking Statements        
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, the therapeutic potential and clinical benefits of BIO89-100, the safety and tolerability of BIO89-100, future clinical development plans for BIO89-100, including the Phase 2b study and open-label paired biopsy histology cohort and the anticipated timing for such plans. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the SEC), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the timing and outcome of 89bio’s initiation of the next trial in NASH; 89bio’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; the effect of the COVID-19 pandemic on 89bio’s clinical trials and business operations, and the impact of general economic, health, industrial or political conditions in the United States or internationally; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:

Ryan Martins
Chief Financial Officer
[email protected]

Media Contact:

Peter Duckler
773-343-3069
[email protected]

TEMPE, Ariz., Nov. 13, 2020 (GLOBE NEWSWIRE) — VirTra, Inc. (NASDAQ: VTSI), a global provider of training simulators for the law enforcement, military, educational, and commercial markets, today announced that its chief financial officer, Judy Henry, intends to retire in December 2020. As a result, VirTra’s board of directors has initiated a search for a permanent replacement.

“It has been my pleasure and privilege to serve as VirTra’s CFO and to be part of the company’s growth,” said Judy Henry. “To make the transition as smooth as possible, I intend to stay on through early December 2020. I’m very grateful to have been part of VirTra these last four years and especially proud of everything the team has accomplished during that time. These accomplishments have culminated in the company being in its strongest position ever, and I am confident the team will be able to continue building on this success in the years ahead.”

Bob Ferris, chairman and chief executive officer of VirTra, commented, “On behalf of our entire organization, I’d like to thank Judy for the numerous contributions she made to VirTra during a critical stage of our company’s evolution. She’s been an integral part of our leadership team, and we’re very grateful to have benefitted from her expertise. We wish her well, and her accomplishments at VirTra will long be remembered.”

Jeffrey Brown, chairman of VirTra’s audit committee, added, “We’re fortunate to have Judy stay on as VirTra’s CFO into December to help us with the transition period. The board of directors has already initiated a search for a permanent replacement to help lead VirTra through its next phase of growth.”

About
VirTra

VirTra (NASDAQ: VTSI) is a global provider of judgmental use of force training simulators, firearms training simulators and driving simulators for the law enforcement, military, educational and commercial markets. The company’s patented technologies, software, and scenarios provide intense training for de-escalation, judgmental use-of-force, marksmanship and related training that mimics real-world situations. VirTra’s mission is to save and improve lives worldwide through practical and highly effective virtual reality and simulator technology. Learn more about the company at www.VirTra.com.

Investor Relations Contact:
Matt Glover or Charlie Schumacher
[email protected]
949-574-3860

MIDDLEFIELD, Ohio, Nov. 13, 2020 (GLOBE NEWSWIRE) — Middlefield Banc Corp. (NASDAQ: MBCN) today announced the resumption and increase of the Company’s stock repurchase program (the “Program”).

The Program commenced April 19, 2019, but repurchases under the Program were temporarily suspended in late March, 2020 due to the COVID-19 pandemic. At the time that the Program was suspended, the Company had repurchased 157,032 shares from the 300,000-share authorization under the Program.

On November 9, 2020, the Board authorized an increase to the Program by an additional 157,032 shares for a total of 300,000 shares that may be repurchased. This equates to approximately 4.7% of the Company’s 6,378,960 outstanding shares at November 3, 2020. The Program may be modified, suspended or terminated by the Company at any time.

“We entered the COVID-19 crisis with favorable asset quality and strong capital levels, and we believe our stock is trading at a compelling valuation. This share repurchase program demonstrates our confidence in the strength of our business and our continued commitment to delivering value to our shareholders,” said Thomas G. Caldwell, Middlefield’s President and Chief Executive Officer.

The resumption of the stock repurchase program and increased share repurchase authorization position the Company to enhance the value of its stock and to manage its capital. The Board’s action will allow management to make repurchases, without further board approval, when stock purchases are deemed prudent. The Board believes that a stock repurchase plan is an important tool that can be utilized to enhance long-term shareholder value. Share repurchases will be made periodically as permitted by securities laws and other legal requirements and will be subject to market conditions as well as other factors. Repurchases may be made in the open market, through block trades or otherwise, and in privately negotiated transactions. Share purchases may be commenced or suspended at any time without notice.

Middlefield Banc Corp., headquartered in Middlefield, Ohio, is the bank holding company of The Middlefield Banking Company with total assets of $1.36 billion at September 30, 2020. The bank operates 16 full-service banking centers and an LPL Financial® brokerage office serving Beachwood, Chardon, Cortland, Dublin, Garrettsville, Mantua, Middlefield, Newbury, Orwell, Plain City, Powell, Solon, Sunbury, Twinsburg, and Westerville. The Bank also operates a Loan Production Office in Mentor, Ohio.  

Additional information is available at www.middlefieldbank.bank

This press release of Middlefield Banc Corp. and the reports Middlefield Banc Corp. files with the Securities and Exchange Commission often contain “forward-looking statements” relating to present or future trends or factors affecting the banking industry and, specifically, the financial operations, markets and products of Middlefield Banc Corp. These forward-looking statements involve certain risks and uncertainties. There are a number of
important factors that could cause Middlefield Banc Corp.’s future results to differ materially from historical performance or projected performance. These factors include, but are not limited to: (1) a significant increase in competitive pressures among financial institutions; (2) changes in the interest rate environment that may reduce interest margins; (3) changes in prepayment speeds, charge-offs and loan loss provisions; (4) less favorable than expected general economic conditions; (5) legislative or regulatory changes that may adversely affect businesses in which Middlefield Banc Corp. is engaged; (6) technological issues which may adversely affect Middlefield Banc Corp.’s financial operations or customers; (7) the effect of the COVID-19 pandemic, including on our credit quality and business operations, as well as
the pandemic’s
impact on general economic and financial market conditions; (8) changes in the securities markets; or (9) risk factors mentioned in the reports and registration statements Middlefield Banc Corp. files with the Securities and Exchange Commission. Middlefield Banc Corp. undertakes no obligation to release revisions to these forward-looking statements or to reflect events or circumstances after the date of this press release.   

Company Contact:	Investor and Media Contact:
Thomas G. Caldwell President/Chief Executive Officer Middlefield Banc Corp. (440) 632-1666 Ext. 3200 [email protected]	Andrew M. Berger Managing Director SM Berger & Company, Inc. (216) 464-6400 [email protected]

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LOS ANGELES, Nov. 13, 2020 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of HP, Inc. (“HP” or “the Company”) (NYSE: HPQ) investors that acquired securities between November 6, 2015 and June 21, 2016.  

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.

According to the Complaint, the HP made misleading and false statements to the market. HP’s performance was artificially inflated by its sales practices by selling supplies to customers that did not need or want them. Supplies were sold by HP outside of designated regions at massive discounts designed to boost profits. HP’s public statements were false and materially misleading, based on these facts. Investors suffered damages when the truth about HP was made clear to the market .

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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