Market Newsdesk

MOORESTOWN, N.J., Nov. 30, 2020 (GLOBE NEWSWIRE) — Tabula Rasa HealthCare, Inc. (“TRHC”) (NASDAQ: TRHC), a healthcare technology company advancing the field of medication safety, today announced the appointment of Celynda G.Tadlock, PharmD, MBA as the Company’s Chief Client Officer and EVP of Pharmacy Benefit Services. Dr. Tadlock will be a member of TRHC’s Executive Committee.

“Selecting Dr. Tadlock to serve as TRHC’s Chief Client Officer will enhance and build upon our strategies and services that bring new innovations to clients and development opportunities for TRHC,” said TRHC Chairman and CEO Calvin H. Knowlton, PhD. “Dr. Tadlock’s goal will be to create a persistent focus on the client to support needed action to assure client and Company success. Her expertise in pharmacy benefit management (PBM) and services will transition recent acquisitions quickly and efficiently into a combined organization that leverages TRHC’s proprietary science and services.”

Dr. Tadlock recently launched Impera Healthcare Strategies, where she secured agreements in value-based innovations, market access solutions and industry trends. She supported diverse clients, from evidence-based pathway organizations to blockchain consortia to providers to manufacturers, with common interests in managed care. She developed business strategies and created compelling value propositions for products and services in the payer and PBM market place. 

Previously, Dr. Tadlock was Vice President, Clinical Strategy and Pharmacy Experience at Aetna, a CVS Health Company; served as President and Chief Operating Officer, Pharmacy at Coventry; and held executive roles at Express-Scripts and Anthem. At Aetna, she led all aspects of the pharmacy experience serving 15M members, with 225 million prescriptions and $22B drug spend each year. While at Aetna, she also held the role of Vice President, Clinical, Product and Customer Experience and Vice President, Pharmacy Business Development.

“TRHC looks forward to Dr. Tadlock bringing her expertise to assist TRHC in its growth and profitability, its marketing, clinical and product strategies, and industry and trade relations,” said TRHC President and Chief Marketing & Business Development Officer, Orsula V. Knowlton, PharmD, MBA. “We welcome her to TRHC’s Executive Team.”

Dr. Tadlock is President Elect of Georgia Academy of Managed Care Pharmacy (AMCP) and serves on the AMCP Public Policy Committee. She also has been an active member of Pharmaceutical Care Management Association (PCMA) serving on the Operations Committee and leading the Federal and Legal Subcommittees. She frequently is asked to speak at national stage forums relative to managed care, specialty pharmacy and pharmacy benefit management.

Dr. Tadlock received a Doctor of Pharmacy degree from Mercer University in Atlanta, Georgia and a Master of Business Administration degree from Keller Graduate School of Management.

About Tabula Rasa HealthCare

Tabula Rasa HealthCare (TRHC) provides medication safety solutions empowering healthcare professionals to optimize medication regimens and reduce medication-related risk, specifically targeting adverse drug events. Utilizing its proprietary medication decision science technology, MedWise™, TRHC improves patient outcomes, reduces hospitalizations, and lowers healthcare costs. Additionally, TRHC provides an extensive clinical telepharmacy network across the U.S. Its solutions are trusted by health plans and pharmacies nationwide to help drive value-based payment results. For more information, visit TRHC.com.

Forward-Looking Statements

This press release includes forward-looking statements that we believe to be reasonable as of today’s date, including statements regarding Medication Risk Mitigation technology. Such statements are identified by use of the words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “should,” and similar expressions. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the need to innovate and provide useful products and services; risks related to changing healthcare and other applicable regulations; increasing consolidation in the healthcare industry; managing our growth effectively; our ability to adequately protect our intellectual property; and the other risk factors set forth from time to time in our filings with the SEC, including those factors discussed under the caption “Risk Factors” in our most recent annual report on Form 10-K, filed with the SEC on March 2, 2020, and in subsequent reports filed with or furnished to the SEC, copies of which are available free of charge within the Investor Relations section of the TRHC website ir.trhc.com or upon request from our Investor Relations Department. Any forward-looking statement speaks only as of the date on which it was made. TRHC assumes no obligation and does not intend to update these forward-looking statements, except as required by law, to reflect events or circumstances occurring after today’s date.

TRHC Media Contact

Dianne Semingson
[email protected]
T: (215) 870-0829

TRHC Investor Contact

Frank Sparacino
[email protected]
T: (866) 648-2767

AUSTIN, Texas, Nov. 30, 2020 (GLOBE NEWSWIRE) — Vital Farms (Nasdaq: VITL), a Certified B Corporation that offers a range of ethically produced pasture-raised foods nationwide, today announced that Russell Diez-Canseco, President and Chief Executive Officer, and Jason Dale, Chief Financial Officer and Chief Operating Officer, will present at two upcoming virtual investor conferences. The conference details include:

• On Thursday, December 3, 2020, Diez-Canseco and Dale will host a fireside chat at the Morgan Stanley Global Consumer & Retail Conference. The fireside chat will take place at 1:00 p.m. ET, or 12:00 p.m CT. Participants may access the live webcast under the “Events & Presentations” tab on the Vital Farms Investor Relations site: https://investors.vitalfarms.com/investor-relations. Following the discussion, a replay will be archived on the Company’s Investor Relations site.
• On Wednesday, December 9, 2020, Diez-Canseco will participate in a panel discussion titled “Food of the Future” at the BMO 2020 Growth & ESG Conference. The panel will take place at 11:00 a.m. ET, or 10:00 a.m. CT. For more information, please contact your BMO representative.

About Vital Farms

Vital Farms, a Certified B Corporation, offers a range of ethically produced pasture-raised foods nationwide. Started on a single farm in Austin, Texas, in 2007, Vital Farms is the leading U.S. brand of pasture-raised eggs and butter by retail dollar sales. Vital Farms’ ethics are exemplified by its focus on the humane treatment of farm animals and sustainable farming practices. In addition, as a Delaware Public Benefit Corporation, Vital Farms also prioritizes the long-term benefits of each of its stakeholders, including farmers and suppliers, customers and consumers, communities and the environment, and crew members and stockholders. Vital Farms’ pasture-raised products, including shell eggs, butter, hard-boiled eggs, ghee, egg bites and liquid whole eggs, are sold in approximately 16,000 stores nationwide.

Contact

ICR
Ashley DeSimone
[email protected]
646.677.1827

SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced that management will host a virtual event entitled “The Power of hnCD16” on Friday, December 4, 2020 at 4:30 PM EDT.

The event will highlight the unique therapeutic features and functionality of the Company’s proprietary high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, a core component incorporated in its iPSC-derived NK cell product candidates. The Company’s hnCD16 Fc receptor is designed to maximize antibody-dependent cellular cytotoxicity, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

The live webcast of the presentation can be accessed under “Events & Presentations” in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event. The event is not an official program of the 62^nd American Society of Hematology (ASH) Annual Meeting and Exposition.

About Fate Therapeutics’ iPSC Product Platform

The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company’s immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Contact:

Christina Tartaglia
Stern Investor Relations, Inc.
212.362.1200
[email protected]

TORONTO, Nov. 30, 2020 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) announced today that Sonalleve^® has received U.S. Food and Drug Administration (“FDA”) approval under a Humanitarian Device Exemption (“HDE”) for the treatment of osteoid osteoma.

Osteoid osteoma is a non-cancerous bone tumor that occurs most often in the long bones of the leg, such as the femur and tibia, of young children and adolescents. An osteoid osteoma causes a dull, aching pain that is moderate in intensity, but can worsen and become severe, especially at night. Computed tomography(CT)-guided radiofrequency ablation (RFA), the most commonly used osteoid osteoma treatment, requires drilling through muscle and soft tissue into bone, and also exposes the patient to radiation from the imaging necessary to guide the probe that is inserted to heat and destroy tumor tissue.

Sonalleve^® is an innovative therapeutic platform that combines real-time Magnetic Resonance imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve^® can offer patients suffering with an osteoid osteoma a treatment that can be performed safely with clinical improvement, but without any incisions, needles, or ionizing radiation exposure.

“While we do not expect this FDA HDE approval for Sonalleve^® to have a material impact on revenues in the near- term, it is nevertheless strategically very important,” said Arun Menawat, Profound’s CEO and Chairman. “Obtaining the first regulatory approval for Sonalleve^® in the U.S. is a significant milestone for the Company and we are making preparations for the U.S. commercial launch in 2021. This positive FDA decision was based on a rigorous safety review and is key to our global expansion strategy for this groundbreaking therapeutic platform as we conduct clinical trials to support additional marketing approvals for the treatment of indications with larger patient populations.”

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO^®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO^® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO^® has the potential to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (BPH). TULSA-PRO^® is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve^®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve^® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve^® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. Often, but not always, forward-looking statements can be identified by
the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical
industry, regulatory
approvals , reimbursement,
economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed.
In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on
Profound
’s
operations, the demand for its products, global supply chains and economic activity in general.
Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
[email protected]
T: 647.872.4849 

ASML reports transactions under its current share buyback program

VELDHOVEN, the Netherlands – ASML Holding N.V. (ASML) reports the following transactions, conducted under ASML’s current share buyback program.

Date	Total repurchased shares	Weighted average price	Total repurchased value
23-Nov-20	40,191	360.47	14,487,661.02
24-Nov-20	50,071	358.70	17,960,284.44
25-Nov-20	58,068	355.11	20,620,409.02
26-Nov-20	47,627	358.90	17,093,377.93
27-Nov-20	15,699	361.41	5,673,847.18

ASML’s current share buyback program was announced on 22 January 2020, and details are available on our website at https://www.asml.com/en/news/share-buyback

This regular update of the transactions conducted under the buyback program is to be made public under the Market Abuse Regulation (Nr. 596/2014).

Media Relations Contacts	Investor Relations Contacts
Monique Mols, phone +31 6 528 444 18	Skip Miller, phone +1 480 235 0934
	Marcel Kemp, phone +31 40 268 6494

VANCOUVER, British Columbia, Nov. 30, 2020 (GLOBE NEWSWIRE) — SHARC International Systems Inc. (CSE: SHRC) (FSE: IWIA) (OTCQB: INTWF) (“SHARC Energy” or the “Company”) has filed its financial results for the third quarter ended September 30, 2020 on www.sedar.com. All figures are in CDN unless otherwise noted.

Third Quarter and Year to date Financial Highlights:

• Revenue for the three months ended September 30, 2020 (“Q3 2020”) and the nine months ended September 30, 2020 (“YTD 2020”) was $0.426M and $0.594M, respectively, representing an increase of $0.348M and $0.470M from the three months ended September 30, 2019 (“Q3 2019”) and nine months ended September 30, 2020 (“YTD 2019”). This represented the largest revenue quarter for the Company in the past 8 most recent quarters and its largest since the quarter ended March 31, 2018.
• Loss from continuing operations for Q3 2020 is $1.042M compared to $0.907M for Q3 2019, an increase of $0.135M. Loss from continuing operations for YTD 2020 is $1.948M compared to $2.679M for YTD 2019, a decrease of $0.731M.
• Adjusted EBITDA¹ Loss of $0.422M in Q3 2020 compared to $0.482M in Q2 2019 and $1.312M YTD 2020 compared to $1.652M YTD 2019.
• As of November 30, 2020, the Company has Sales Pipeline² of $3.9M and Sales Order Backlog³ of $0.161M.
• The Company has $0.913M of working capital as of September 30, 2020.

Q3 2020 Accomplishments

• During Q3 2020, the Company delivered 2 PIRANHA units, representing the first PIRANHA shipment to the US and 2^nd to Australia which is the 1^st unit to be installed in a senior’s living facility. The Company also delivered and installed wastewater holding tanks to a site for a district energy project expected to commence and be fulfilled in 2021.
• On July 16, 2020, the Company hired Matt Engelhardt as its Chief Operating Officer.
• On July 29, 2020, the Company announced it has accelerated the expiry of 2,972,404 common share purchase warrants with an exercise price of $0.10. These warrants have been exercised in full and additional warrants have been exercised providing proceeds of $0.315M.
• On September 15, King County Council unanimously approved legislation allowing three wastewater heat recovery projects. SHARC Energy participated in the opportunity that King County provided for public consultation with regards to the development of the template contract that could be used for agreements with private parties (users) for sewer heat recovery. This is significant development for the industry of wastewater energy recovery in North America.

• During Q3 2020, the Company saw the conversion of $580,000 of convertible debt into 5.8M common shares.

Subsequent Accomplishments

• On October
  14
  
  ^th
  
  , 2020, utilities, municipalities and private sector investors in the United States were shown results achieved during a three-month demonstration of a unique wastewater thermal recovery technology PIRANHA HC at the EPRI sponsored Incubatenergy Labs and Ameren Accelerator Demo Day. Key results of the demonstration included:
  • 61 per cent energy savings reported by building management.
  • 99 per cent GHG reduction from gas boiler use.
  • Production of 100% of the hot water at 140°F, completely offsetting the use of gas boilers.
  • An average Co-efficiency of Performance (“COP”) for hot-water production of over 3.5 over the project term and peak COP of over 5.
  • Reduction of thermal water pollution. PIRANHA HC removes the heat from wastewater, so that it reduces impact on ambient water temperature in rivers, lakes, and oceans when it is released.

• SHARC Energy has been selected to participate in two programs through Global Affairs Canada Trade Commissioners Service. The Company will be participating in the Canadian Technology Accelerator focused on promoting Canadian Cleantech companies in Southeast Asia and more specifically, the ASEAN region. The Company is also participating in a B2B matchmaking Virtual Trade Mission for Canadian Water and Wastewater companies and Brazilian companies and organization in the public and private sector.

“Q3 2020 is the largest revenue quarter we have had in over two years and saw a number of promising developments for wastewater energy recovery and SHARC Energy,” says Hanspaul Pannu, Chief Financial Officer of SHARC Energy, “The Company is encouraged by the results and feedback from the EPRI demonstration and the relationships created. As the Company continues to bring awareness to the PIRANHA as a key player in the energy retrofit market, it will look to leverage these relationships created to penetrate the market. We are focused on driving growth through additions to sales pipeline and sales order backlog generation and that is where the focus lies for the remainder of 2020 and moving forward.”

¹ Adjusted EBITDA is a Non-IFRS measure. Please see discussion and reconciliation of Alternative Performance Measures and Non-IFRS measures in the Q3 2020 Management Discussion and Analysis (“MD&A”).
² Sales Pipeline is a Non-IFRS measure. Please see discussion of Alternative Performance Measures and Non-IFRS Measures in the Q3 2020 MD&A.
³ Sales Order Backlog is a Non-IFRS measure. Please see discussion of Alternative Performance Measures and Non-IFRS Measures in the Q3 2020 MD&A.

About SHARC Energy

SHARC International Systems Inc. is a world leader in wastewater energy recovery. SHARC systems recycle thermal energy from wastewater, generating one of the most energy efficient and economical systems for heating, cooling and hot water production for commercial, residential and industrial buildings, reducing their energy costs and carbon footprint. SHARC Energy is publicly traded in Canada (CSE: SHRC), the United States (OTCQB: INTWF) and Germany (Frankfurt: IWIA).

Further information about the Company is available on our website at www.SHARCenergy.com or SEDAR at www.sedar.com.

ON BEHALF OF THE BOARD

“Lynn Mueller”

Chairman and Chief Executive Officer

For investor inquiries, please contact:

Jason Shepherd
Investor Relations
SHARC Energy
Telephone: (250) 212-2122
Email: [email protected]

For media inquiries, please contact

Mike Tanyi
Director of Marketing and IT
SHARC Energy
Telephone: (250) 212-2122
Email: [email protected]

The Canadian Securities Exchange does not accept responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements


Certain statements contained in this news release may constitute forward-looking information. Forward-looking information is often, but not always, identified
by the use of
words such as “anticipate”, “plan”, “estimate”, “expect”, “may”, “will”, “intend”, “should”, and similar expressions. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. SHARC
Energy
‘s actual results could differ materially from those anticipated in this forward-looking information as a result of regulatory decisions, competitive factors in the industries in which the Company operates, prevailing economic conditions, and other factors, many of which are beyond the control of the Company. SHARC
Energy
believes that the expectations reflected in the forward-looking information are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking information should not be unduly relied upon. Any forward-looking information contained in this news release represents the Company’s expectations as of the date
hereof and
is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward-looking information whether
because of
new information, future events or otherwise, except as required by applicable securities legislation.

— Single-Ascending Doses ofALLN-346 Oral Enzyme Well-Tolerated —
— Non-Absorption of ALLN-346 Demonstrated —
— Advancing to Phase 1b Multiple–Ascending Dose Study and Phase 2 Proof-of-Concept Trial; Initial Data from Both Studies Expected in Second Half of 2021 —

NEWTON, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) — Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced clinical data from its Phase 1 trial of ALLN-346 in healthy volunteers. ALLN-346 is an investigational, orally administered, novel urate-degrading enzyme that has been designed for activity and stability in the gastrointestinal (GI) tract, and is intended for the treatment of hyperuricemia in patients with gout and chronic kidney disease (CKD).

The double-blind, placebo-controlled, single-ascending dose study enrolled 24 healthy volunteers. Groups of eight study participants were randomized 3:1 to ALLN-346 or matching placebo in three sequential cohorts dosed orally with three, six, or 12 capsules in one day. Each capsule of ALLN-346 contained a target dose of 90 mg of enzyme, equivalent to 2,250 units. ALLN-346 was well-tolerated with no clinically significant safety signals and no dose-limiting toxicities observed in any cohort up to the highest administered dose. In addition, assay of serum samples by ELISA immunoassay demonstrated that ALLN-346 was not absorbed systemically, supporting that its mechanism of action appears to be restricted to the GI tract.

“We are very encouraged by the preliminary safety and tolerability data collected for ALLN-346 in healthy volunteers,” said Louis Brenner, M.D, President and Chief Executive Officer of Allena. “While there are several classes of approved therapies to treat hyperuricemia and gout, all have significant limitations in the CKD population due to toxicity-related concerns, dose limitations, and contraindications. We specifically designed ALLN-346 to overcome these challenges, using our proprietary platform to create a stable oral enzyme that is intended to act via the gut-kidney axis, degrading urate in the GI tract and reducing the systemic and metabolic burden of urate on the kidneys. The results announced today support our belief in ALLN-346’s gut-restricted mechanism of action and support its further development as a scientifically-driven therapeutic candidate for the approximately 375,000 people living with gout and moderate-to-severe CKD. We are now preparing to advance ALLN-346 into separate Phase 1b multiple-ascending dose and Phase 2 clinical studies, and look forward to further progress, including potential proof-of-concept data, in 2021.”

Subject to feedback from the U.S. Food and Drug Administration, Allena expects to initiate a Phase 1b multiple-ascending dose trial in healthy volunteers and a Phase 2 proof-of-concept trial in patients with hyperuricemia and CKD in the first half of 2021, with initial data from both studies expected in the second half of 2021.

About Hyperuricemia

Hyperuricemia, or elevated levels of uric acid in the blood, results from overproduction or insufficient excretion of urate, or often a combination of the two. Hyperuricemia is associated with gout, a kind of arthritis caused by excess uric acid in the blood that leads to the formation of hard crystals in the joints. Hyperuricemia can also lead to increased uric acid excretion in the urine and subsequently to kidney stone formation and kidney damage also known as urate nephropathy. In addition, hyperuricemia has been linked to hypertension, CKD, glucose intolerance, dyslipidemia, insulin resistance and obesity.

CKD patients with hyperuricemia and gout are often not optimally managed due to limitations of available therapies, including decreased tolerability, dose restrictions, drug-drug interactions, and contraindications. According to a published study, there are approximately 375,000 patients in the United States with hyperuricemia and CKD on urate lowering therapy who have uncontrolled gout.¹

_______________
¹ Lim, J., Fu, A., Reasner, D. & Taylor, D. (2017, April). Prevalence of CKD and Uncontrolled Gout Among US Adults: Results From NHANES 2007–2012. Poster presented at the National Kidney Foundation Spring Clinical Meetings, Orlando, FL.

About ALLN-346

ALLN-346 is an investigational, orally administered, novel, engineered urate oxidase that has been optimized for stability in the GI tract and high production yield. Allena has designed ALLN-346 to degrade urate in the GI tract and in turn, reduce the urate burden on the kidney and lower the risk of urate-related complications. ALLN-346 is targeted to lower serum uric acid in patients with CKD, whose renal function is decreased and who have diminished capacity for urinary excretion of uric acid.

About Allena Pharmaceuticals

Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena’s lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1b multiple-ascending dose study and a Phase 2 proof-of-concept study planned for 2021.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the clinical data from Allena’s Phase 1 trial of ALLN-346; Allena’s future development plans for ALLN-346; Allena’s pipeline of oral enzyme therapeutic candidates and Allena’s plans to build a commercial organization. Any forward-looking statements in this press release 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. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena’s clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena’s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena’s dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Item 1A of Part I of Allena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

Investor Contact

Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
[email protected]

Media Contact

Adam Daley
Berry & Company Public Relations
212-253-8881
[email protected]

BOSTON, Nov. 30, 2020 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eprenetapopt in the treatment of patients with TP53 mutant acute myeloid leukemia (AML). The Company previously received Breakthrough Therapy, Orphan Drug and Fast Track designations for eprenetapopt in the treatment of patients with TP53 mutant myelodysplastic syndromes (MDS).

The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate’s development plan as well as eligibility for accelerated approval and priority review.

“We are pleased to have received Fast Track designation for eprenetapopt in the treatment of TP53 mutant AML, a cancer for which outcomes are poor and there are no current therapeutic options specifically for these patients,” said Eyal C. Attar, M.D., Chief Medical Officer of Aprea. “Emerging data from our AML trials evaluating eprenetapopt with azacitidine, and with eprenetapopt, azacitidine and venetoclax, are promising and we continue to enroll patients to identify the best treatment regimen. As these data mature in 2021, we look forward to continued interaction with FDA as we map out opportunities for an accelerated pathway to potential approval.”

About A
prea
Therapeutics, Inc.

Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53. The Company’s lead product candidate is eprenetapopt (APR-246), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Fast Track designation from the FDA for AML,and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. APR-548, a next generation small molecule reactivator of mutant p53, is being developed for oral administration. For more information, please visit the company website at www.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

About p53
, eprenetapopt
and APR-
548

The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.

E
prenetapopt (APR-246) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – thereby inducing programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with eprenetapopt in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with eprenetapopt has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.

A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Fast Track designation from the FDA for AML, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.

APR-548 is a next-generation small molecule p53 reactivator. APR-548 has demonstrated high oral bioavailability, enhanced potency relative to eprenetapopt in TP53 mutant cancer cell lines and has demonstrated in vivo tumor growth inhibition following oral dosing of tumor-bearing mice. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin in the first quarter of 2021

Forward-Looking Statement

Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our clinical trials, regulatory submissions and projected cash position. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties.  Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings with the U.S. Securities and Exchange Commission.  For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Source:  Aprea Therapeutics, Inc.

Corporate Contacts:

Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385

Gregory A. Korbel
Vice President of Business Development
617-463-9385

Ebitda Margin Acceleration Continues

Business Remains Robust Into Fiscal Q1 2021

CINCINNATI, Nov. 30, 2020 (GLOBE NEWSWIRE) — Protech Home Medical Corp. (the “Company” or “Protech”) (TSXV:PTQ; OTCQX:PTQQF), a U.S. based leader in the home medical equipment industry, focused on end-to-end respiratory care‎, is pleased to announce record preliminary financial results for the fourth quarter of 2020, ending September 30, 2020.

Preliminary Financial Results – Quarter Ended September 30, 2020

• Revenue in the range of $26.1 million to $26.5 million. The Company experienced robust organic growth in the fourth quarter, however the reported CAD revenue amount was offset by a weakening of the US dollar relative the Canadian dollar by approximately 4%.
• Adjusted EBITDA in the range of $5.6 million to $6.1 million.

“We are extremely satisfied with the record preliminary financial performance in the fourth quarter and the foundation that has been built for continued aggressive growth in 2021 and beyond. It is the resilience of the entire team, whilst dealing with the impact of a global pandemic that allowed us to surpass our financial objectives in the fourth quarter and for the full year of 2020,” commented Greg Crawford, CEO and Chairman of Protech. “We have seen our sleep business pick up in the back half of the year, approaching levels seen early in 2020, and are optimistic the sleep business will return to and surpass pre-pandemic levels in 2021. As a whole, our business remains robust into our fiscal first quarter of 2021, our M&A pipeline is full, and we are well capitalized with our pristine balance sheet to capture the significant opportunities at our front door.

We are building a world class clinical respiratory organization focused on superior patient care, and I am extremely proud of the work by our team as evidenced in our strong results. Furthermore, we are proud to report there has been a surge in the usage of our tele-health platform, and we are proud to offer both remote and in-person options to our patients as it comes to the education of utilizing our equipment. We believe the need for in-home healthcare will only continue to accelerate across the country, and hospitals will continue to provide Protech with continued opportunity, and we are ready to capitalize. We felt it extremely important to continue to keep our shareholders apprised with our financial performance in real time. We look forward to sharing our full financial results and commentary in January.”

Chief Financial Officer, Hardik Mehta added, “Our record preliminary results speak to the continued operational execution across the organization. We have a strong interconnected platform that allows us to build our business organically and continue to lather on acquired businesses to the platform in a seamless fashion. Furthermore, the recent decision by CMS to not award competitive bidding contracts for any of the 13 ‎product categories for Round 2021 is extremely ‎bullish for our current business as it provides us with a significantly clearer outlook on the margin ‎for our overall product mix. Our Adjusted EBITDA margins continue to exceed our expectations and we are extremely confident in our ability to continue with this trajectory.”

Protech provides home delivery and efficient online set-up of equipment for, primarily, chronic conditions. The Company operates out of 48 locations in 10 states with over 17,000 referring physicians and approximately 110,000 current active patients.

ABOUT PROTECH HOME MEDICAL

The Company provides in-home monitoring and disease management services including end-to-end respiratory solutions for patients in the United States healthcare market. It seeks to continue to expand its offerings to include the management of several chronic disease states focusing on patients with heart or pulmonary disease, sleep disorders, reduced mobility and other chronic health conditions. The primary business objective of the Company is to create shareholder value by offering a broader range of services to patients in need of in-home monitoring and chronic disease management. The Company’s organic growth strategy is to increase annual revenue per patient by offering multiple services to the same patient, consolidating the patient’s services and making life easier for the patient.

Forward-Looking Statements

Certain statements contained in this press release constitute “forward-looking information” as such term is ‎‎‎defined ‎in applicable Canadian securities legislation. The words “may”, “would”, “could”, “should”, “potential”, ‎‎‎‎”will”, ‎‎”seek”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions as they relate ‎‎‎to the ‎Company, including: t
he Company expecting continued aggressive growth in 2021 and beyond; the Company being optimistic the sleep business will return to and surpass pre-pandemic levels in 2021; the Company sharing full financial results and commentary in January; and
the Company being extremely confident in its ability to continue with its Adjusted EBITDA trajectory
; are intended to identify ‎forward-looking information. All statements other than ‎statements of ‎‎historical fact may be forward-looking ‎information. Such statements reflect the Company’s current ‎views and ‎‎intentions with respect to future events, and ‎current information available to the Company, and are ‎subject to ‎‎certain risks, uncertainties and assumptions. Many factors ‎could ‎cause the actual results, performance or ‎achievements that may be expressed or ‎implied by such forward-‎looking ‎information to vary from those described ‎herein should one or more of these risks ‎or uncertainties ‎materialize. ‎Examples of such risk factors include, without ‎limitation: credit; market (including ‎equity, commodity, ‎foreign ‎exchange and interest rate); liquidity; operational ‎‎(including technology and ‎infrastructure); ‎reputational; ‎insurance; strategic; regulatory; legal; environmental; ‎capital adequacy; the ‎general business and ‎economic ‎conditions in the regions in which the Company operates; the ‎ability of the ‎Company to execute on key ‎priorities, ‎including the successful completion of acquisitions, business ‎retention, and ‎strategic plans and to ‎attract, develop ‎and retain key executives; difficulty integrating newly ‎acquired businesses; ‎the ability to ‎implement business ‎strategies and pursue business opportunities; low profit ‎market segments; ‎disruptions in or ‎attacks (including ‎cyber-attacks) on the Company’s information technology, ‎internet, network ‎access or other ‎voice or data ‎communications systems or services; the evolution of various types of ‎fraud or other ‎criminal ‎behavior to which ‎the Company is exposed; the failure of third parties to comply with their ‎obligations to ‎the ‎Company or its ‎affiliates; the impact of new and changes to, or application of, current laws and ‎regulations; ‎‎decline of ‎reimbursement rates; dependence on few payors; possible new drug discoveries; a novel ‎business model; ‎‎‎dependence on key suppliers; granting of permits and licenses in a highly regulated business; the ‎overall difficult ‎‎‎litigation environment, including in the U.S.; increased competition; changes in foreign currency ‎rates; increased ‎‎‎funding costs and market volatility due to market illiquidity and competition for funding; the ‎availability of funds ‎‎‎and resources to pursue operations; critical accounting estimates and changes to accounting ‎standards, policies, ‎‎‎and methods used by the Company; the occurrence of natural and unnatural catastrophic events ‎‎and claims ‎‎‎resulting from such events; and risks related to COVID-19 including various recommendations, orders ‎‎and ‎‎measures of governmental ‎authorities ‎to try to limit the pandemic, including travel restrictions, border closures, ‎‎‎‎non-essential business ‎closures, ‎quarantines, self-isolations, shelters-in-place and social distancing, disruptions ‎‎to ‎‎markets, economic ‎activity, ‎financing, supply chains and sales channels, and a deterioration of general ‎‎economic ‎‎conditions ‎including a ‎possible national or global recession‎; as well as those risk factors discussed or ‎‎referred to in ‎‎the Company’s disclosure ‎documents filed with the securities regulatory authorities in certain ‎‎provinces of Canada ‎‎and available at ‎www.sedar.com. Should any factor affect the Company in an unexpected ‎‎manner, or should ‎‎assumptions ‎underlying the forward-looking information prove incorrect, the actual results or ‎‎events may differ ‎‎materially ‎from the results or events predicted. Any such forward-looking information is ‎‎expressly qualified in its ‎‎entirety by ‎this cautionary statement. Moreover, the Company does not assume ‎‎responsibility for the accuracy or ‎‎‎completeness of such forward-looking information. The forward-looking ‎‎information included in this press release ‎is ‎‎made as of the date of this press release and the Company undertakes ‎‎no obligation to publicly update or revise ‎any ‎‎forward-looking information, other than as required by applicable ‎‎law.‎‎

Non-GAAP Measures

This press release refers to “Adjusted EBITDA” which is a non-GAAP and non-IFRS financial measure that does not have a standardized meaning prescribed by GAAP or IFRS. The Company’s presentation of this financial measure may not be comparable to similarly titled measures used by other companies. This financial measure is intended to provide additional information to investors concerning the Company’s performance. Adjusted EBITDA is defined as EBITDA excluding stock-based compensation. Adjusted EBITDA is a non-IFRS measure the Company uses as an indicator of financial health and excludes several items which may be useful in the consideration of the financial condition of the Company, including interest expense, income taxes, depreciation, amortization, stock-based compensation, and change in fair value of debentures and financial derivatives‎. The following table shows our non-IFRS measure (Adjusted EBITDA) reconciled to our net income for the ‎indicated period:

		Three months ended September 30, 2020
		($ in millions)
Net income (loss)	$	(3.0) – (2.7)
Loss from discontinued operations		0.7 – 0.8
Income (loss) from continuing operations		(2.3) – (1.9)
Add back:
Depreciation and amortization		4.9 – 4.9
Interest expense, net		0.6 – 0.6
Change in fair value of derivative and other financial costs		2.3 – 2.4
Provision for income taxes		0.1 – 0.1
EBITDA	$	5.6 – 6.1
Stock-based compensation		0.0 – 0.0
Adjusted EBITDA	$	5.6 – 6.1

Preliminary Financial Metrics

This press release contains certain pre-released third quarter financial metrics. The third quarter financial ‎metrics contained in this press release are preliminary and represent the most current information available to the ‎Company’s management, as financial closing procedures for the three and nine months ended September 30, 2020 are ‎not yet complete. The Company’s actual consolidated financial statements for such period may result in material ‎changes to the financial metrics summarized in this press release (including by any one financial metric, or all of ‎the financial metrics, being below or above the figures indicated) as a result of the completion of normal quarter ‎end accounting procedures and adjustments, and also what one might expect to be in the final consolidated ‎financial statements based on the financial metrics summarized in this press release. Although the Company ‎believes the expectations reflected in this press release are based upon reasonable assumptions, the Company can ‎give no assurance that actual results will not differ materially from these expectations.‎

Unless otherwise specified, all dollar amounts in this press release are expressed in Canadian dollars.‎

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.

For further information please visit our website at www.protechhomemedical.com, or contact:

Cole Stevens
VP of Corporate Development
Protech Home Medical Corp.
859-300-6455
[email protected]

Gregory Crawford
Chief Executive Officer
Protech Home Medical Corp.
859-300-6455
[email protected]

RYE BROOK, N.Y., Nov. 30, 2020 (GLOBE NEWSWIRE) — Schultze Special Purpose Acquisition Corp. (NASDAQ: SAMA, SAMAW, and SAMAU) (“SAMA”) and Clever Leaves International Inc. (“Clever Leaves”) announced today that the U.S. Securities and Exchange Commission (“SEC”) has declared effective the registration statement on Form S-4 (as amended to the date hereof, the “Registration Statement”). The Registration Statement includes a proxy statement/prospectus in connection with the special meeting of SAMA stockholders to consider the previously announced business combination (the “Business Combination”) with Clever Leaves pursuant to which a newly formed holding company, Clever Leaves Holdings Inc. (“Holdco”), will acquire SAMA and Clever Leaves.

SAMA has mailed the definitive proxy statement/prospectus relating to the special meeting of SAMA’s stockholders, which will be held on Thursday, December 17, 2020 at 11:00 a.m. Eastern time.

The proxy statement/prospectus is being mailed to SAMA’s stockholders of record as of the close of business on November 16, 2020 (the “Record Date”). Should the Business Combination be approved by stockholders, SAMA and Clever Leaves anticipate closing the Business Combination on or about December 18, 2020, subject to satisfaction or waiver of customary closing conditions.

About
Schultze Special Purpose Acquisition Corp.

Schultze Special Purpose Acquisition Corp. is a blank check company formed for the purpose of entering into a merger, stock exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities. SAMA’s sponsor is an affiliate of Schultze Asset Management, LP, an alternative investment management firm founded in 1998 that focuses on distressed, special situation and event-driven securities and has invested over $3.2 billion since inception with a notable track-record through its active investment strategy. SAMA itself is backed by an experienced team of operators and investors with a successful track-record of creating material value in public and private companies.

About Clever Leaves International Inc.

Clever Leaves is a multi-national cannabis company with a mission to operate in compliance with federal and state laws and with an emphasis on ecologically sustainable, large-scale cultivation and pharmaceutical-grade processing as the cornerstones of its global cannabis business. With operations and investments in the United States, Canada, Colombia, Germany and Portugal, Clever Leaves has created an effective distribution network and global footprint, with a foundation built upon capital efficiency and rapid growth. Clever Leaves aims to be one of the industry’s leading global cannabis companies recognized for its principles, people, and performance while fostering a healthier global community.

Additional Information and Where to Find It

The Registration Statement includes a prospectus with respect to Holdco’s securities to be issued in connection with the Business Combination and a proxy statement with respect to SAMA’s stockholder meeting at which SAMA’s stockholders will be asked to vote on the proposed Business Combination. SAMA, Clever Leaves and Holdco urge investors, stockholders and other interested persons to read the Registration Statement, including the proxy statement/prospectus, as well as other documents filed with the SEC, because these documents contain important information about the Business Combination. SAMA is mailing a definitive proxy statement and other relevant documents to its stockholders as of the Record Date. SAMA’s stockholders will also be able to obtain a copy of such documents, without charge, by directing a request to: Schultze Special Purpose Acquisition Corp, 800 Westchester Avenue, Suite 632, Rye Brook, New York 10573; e-mail: [email protected]. These documents can also be obtained, without charge, at the SEC’s web site (http://www.sec.gov).

Participants in Solicitation

SAMA, Clever Leaves, Holdco and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of SAMA stockholders in connection with the Business Combination. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to SAMA’s stockholders in connection with the Business Combination is set forth in the definitive proxy statement/prospectus contained in the Registration Statement. Information concerning the interests of SAMA’s and Clever Leaves’ participants in the solicitation, which may, in some cases, be different than those of SAMA’s and Clever Leaves’ equity holders generally, is also set forth in the definitive proxy statement/prospectus contained in the Registration Statement.

Forward Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be identified by the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions). Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Factors that may cause such differences include, without limitation, SAMA’s and Clever Leaves’ inability to complete the transactions contemplated by the Business Combination; matters discovered by the parties as they complete their respective due diligence investigation of the other; the inability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, the amount of cash available following any redemptions by SAMA stockholders; the ability to meet Nasdaq’s listing standards in connection with or following the consummation of the Business Combination; costs related to the Business Combination; expectations with respect to future operating and financial performance and growth, including when Clever Leaves or Holdco will become cash flow positive; the timing of the completion of the Business Combination; Clever Leaves’ ability to execute its business plans and strategy and to receive regulatory approvals; potential litigation involving the parties; global economic conditions; geopolitical events, natural disasters, acts of God and pandemics, including, but not limited to, the economic and operational disruptions and other effects of COVID-19; regulatory requirements and changes thereto; access to additional financing; and other risks and uncertainties indicated from time to time in filings with the SEC. Other factors include the possibility that the proposed transaction does not close, including due to the failure to receive required security holder approvals or the failure to satisfy other closing conditions. The foregoing list of factors is not exclusive. Additional information concerning certain of these and other risk factors is contained in SAMA’s most recent filings with the SEC and is contained in the Registration Statement, including the definitive proxy statement/prospectus. All subsequent written and oral forward-looking statements concerning SAMA, Clever Leaves or Holdco, the transactions described herein or other matters and attributable to SAMA, Clever Leaves, Holdco or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Each of SAMA, Clever Leaves and Holdco expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in their expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Schultze Special Purpose Acquisition Corp.
George J. Schultze: [email protected]
Gary M. Julien: [email protected]
(914) 701-5260

Investor Relations
Raphael Gross
ICR
[email protected]
(203) 682-8253

Media Relations
KCSA Strategic Communications
McKenna Miller
[email protected]
(347) 487-6197