Market Newsdesk

Press release

Synairgen plc

(‘Synairgen’ or the ‘Company’)

Synairgen
announces
data
from
Home Cohort
of
SG016
Phase II
trial
of inhaled interferon beta in COVID-19 patients
and
encouraging
combined data for
whole
SG016
trial

• The vast majority of
  Home Cohort
  patients experienced mild disease – only two patients
  were
  hospitalised
  during the treatment period
  , both on placebo
• Home Cohort patients successfully self-administered SNG001
• The
  degree
  of breathlessness
  at start of treatment
  indicate
  s
  which patients should be treated with SNG001 both in hospital and at
  home
• Analysis of
  the
  combined data from
  the
  H
  ospital and
  H
  ome
  C
  ohorts showed
  that the more
  breathless patients are
  significantly more likely (>3 fold)
  to recover on inhaled interferon beta (SNG001) than
  placebo
• The study results r
  einforce confidence in ongoing Phase III study, with data readout on track for H2
  2021
• Synairgen management and scientists to hold a
  30 minute
  
  web
  
  
  cast
  
  
  with live Q&A at
  
  
  9.00
  
  
  BST today
  

Southampton, UK
–
30
April
20
2
1
: Synairgen plc (LSE: SNG), the respiratory company developing inhaled interferon beta (IFN-beta) for the treatment of severe viral lung infections, today announces results from the Home Cohort of its SG016 Phase II trial of SNG001 in SARS-CoV-2 infected patients and data from the combined analysis of the Hospital and Home Cohorts.

SNG001 is a formulation containing IFN-beta for nebulisation, allowing it to be delivered directly into patients’ lungs. A number of studies have reported that the SARS-CoV-2 virus suppresses natural production of IFN-beta and prevents induction of anti-viral responses by infected cells. Furthermore, some people have deficiencies in antiviral IFN signalling that make them more vulnerable to spread of the virus from the nose into the lungs where it can cause severe breathing difficulties. These findings provide a rationale to deliver IFN-beta directly to the surface epithelial cells of the lungs, the primary site of virus infection in the lungs, to prevent severe lower respiratory tract illness caused by the SARS-CoV-2 virus.

The COVID-19
Phase II
s
tudy
(SG016)

Synairgen’s placebo-controlled Phase II trial evaluated SNG001 for the prevention of severe lower respiratory tract (LRT) illness caused by SARS-CoV-2, determined by evaluating change in condition measured using the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period (the primary endpoint). The SG016 trial involved 221 patients in two cohorts:

• Hospital Cohort: 101 patients in the hospital setting, where patients on SNG001, compared to placebo were twice as likely to recover from severe LRT illness to the point where they had ‘no limitation of activities’ (level 1 on the OSCI) without rebound, and had reduced breathlessness.¹
• Home Cohort: 120 ‘at risk’ (aged over 65 or over 50 with a risk factor) patients in the home setting to investigate if SNG001 could prevent development of severe LRT illness.

Trial
f
indings
from
H
ome
C
ohort

In total, only two patients were admitted to hospital during the treatment period, both from the placebo group. The hospitalisation rate (approximately 3% in the placebo group) in this ‘at risk’ COVID-19 patient population was lower than had been originally anticipated, but is in line with other recent large peer-reviewed therapeutic studies.²  Consequently, the prevention of severe LRT illness could not be determined.
The majority of patients exhibited only mild disease which we believe compromised the possibility of showing treatment effects in the Home Cohort. We therefore decided to analyse the subset of patients with most severe symptoms. 

A post hoc analysis was conducted focusing on the 12% of patients who had significant breathlessness (marked or severe, as defined in Note a) at the time they began treatment. In these patients, the recovery to level 1 on the OSCI (‘no limitation of activities’) followed a similar pattern to that observed previously in the hospital population where SNG001 accelerated recovery. This led to an analysis of the impact of SNG001 across the Home and Hospital Cohorts in breathless patients. 

A further finding from the Home Cohort was that patients can successfully initiate treatment “remotely”, self-administering SNG001 at home without the need for a face-to-face meeting with a health care professional, reducing the burden on hospital facilities and minimising the risk of onward infection.

Overall analysis
of
SG016 trial
, combining
Hospital and Home Cohort
s
data

A combined analysis of the Hospital and Home Cohorts data was conducted to explore the impact of the different levels of breathlessness, which is one of the most prominent symptoms of COVID-19, on time to recovery.

• An assessment of placebo patients only indicated that those with marked or severe breathlessness at time of treatment initiation had slower recovery to no limitation of activities than those patients who were not as breathless.  
• In the Hospital Cohort (reported in July 2020) patients were 2.19 times more likely to recover to level 1 on the Ordinal Scale compared to placebo, HR 2.19, p=0.043. The addition of the 12 markedly and severely breathless Home Cohort patients changes the Hazard Ratio to 2.49, p=0.009.
• Interestingly, not all hospitalised patients were markedly or severely breathless at time of treatment initiation. An analysis including only patients who were markedly or severely breathless at the time of treatment initiation, irrespective of whether they were in hospital or at home, showed that those treated with SNG001 (n=33) were 3.41 times more likely to recover than those on placebo (n=36) (HR 3.41 [95% confidence interval 1.47- 7.94], p=0.004).  

Richard Marsden, CEO of Synairgen, said:
“
I am
delighted
by the finding that SNG001 treatment led to
a threefold likelihood of recovery to ‘no limitation of activities’ in the marked
ly
/severe
ly
breathless population
compared to those on placebo
in the home
and
hospital setting
, and
that
further analyses reinforce our previous findings
.
It
increases our con
viction
in the approach we have taken to conduct
an
international Phase III
trial in
hospitalised
patients
requiring supplemental oxyge
n
,
which
is
scheduled to
read out in the second half of this year
.

“As Governments around the world
, such as India
,
look to how future outbreaks and variants may be handled
, our
virus-agnostic therapeutic could help
to
save lives, release pressure on the world’s healthcare systems
,
and
thereby
potentially mitigate
the need for economically costly lockdowns.”

Professor Tom Wilkinson
, Professor of Respiratory Medicine at the University of Southampton, commented:
“The SG016 C
OVID-19
trial of inhaled interferon beta
has been very successful. Although
the vast majority of
non-hospitalised patients had very mild symptoms, the effects of SNG001 on the small group of
markedly and
severely breathless patients
indicated
who might be benefitting most from SNG001. Assessment of breathlessness as a predictor of protracted recovery in the combined Home and Hospital Cohorts showed us that non-breathless patients have no need for the innate immune response boost that interferon beta provides, whereas the patients who were breathless
derive strong benefit from SNG001. This tells us that we should target SNG001 at C
OVID-19
patients with marked or severe breathlessness
where it has a potentially significant benefit
.
”

Professor Nick Francis, Professor of
Primary Care Research
at the University of Southampton, commented:
“
With the knowledge gained from this trial,
identifying
patients
likely
to
benefit from
SNG001 in primary care will be a relatively simple task, starting with an assessment of breathlessness. In parallel with the Phase III trial in the hospital setting
,
there is now an urgent need to assess SNG001 in the non-hospital setting, focussing entirely on breathless C
OVID-19
patients. I look forward to discussing with primary care platform study teams around the world
whether SNG001 can be included in their existing studies
.

“As a GP, I recognise the potential importance of these findings, especially for countries that are still struggling with this disease
at the moment
, and for reducing the burden for patients and the healthcare system in any future waves that may be coming our way.”

Synairgen plans to submit the findings for peer review at an upcoming medical conference or publication.

Members of the management team and scientists at Synairgen will hold a webcast for analysts, followed by a live Q&A, at 9:00 BST today. Please find a link to this webcast here.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No. 596/2014 (‘MAR’).

References

1. The Lancet Respiratory Medicine: “Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial”. Monk, P D PhD, et al., 12 November 2020, accessible here.
2. ‘
   
   https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody
   
   ’
   .

Notes

a. Breathlessness scoring system from the Breathlessness, Cough and Sputum Scale (BCSS)

How much difficulty did you have breathing today?
0 = None – unaware of any difficulty
1 = Mild – noticeable when performing strenuous activity (e.g. running)
2 = Moderate – noticeable even when performing light activity (e.g. bedmaking or carrying groceries)
3 = Marked – noticeable when washing or dressing
4 = Severe – almost constant, present even when resting

For further enquiries, please contact:

Synairgen plc

Richard Marsden, Chief Executive Officer
John Ward, Chief Financial Officer
Tel: + 44 (0) 23 8051 2800

finnCap
(NOMAD and Joint Broker)

Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate Finance)
Alice Lane, Sunila de Silva (ECM)
Tel: + 44 (0) 20 7220 0500

Numis Securities Limited (Joint Broker)

James Black, Freddie Barnfield, Duncan Monteith
Tel: +44 (0) 20 7260 1000

Consilium Strategic Communications (Financial Media and Investor

Relations)

Mary-Jane Elliott, Jessica Hodgson, Olivia Manser
[email protected]
Tel: +44 (0) 20 3709 5700

MKC Strategies, LLC (US Media Relations)


Mary Conway
[email protected]
Tel: +1 516 606 6545

Notes for Editors

About Synairgen

Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic. 

Synairgen is currently focused on developing its product candidate, SNG001 (inhaled interferon beta) for the treatment of COVID-19. SNG001 is potentially the first host-targeted broad-spectrum antiviral treatment delivered directly into the lungs. The Company is evaluating nebulised SNG001 in its Phase III clinical programme, which has been deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). SNG001 has also been granted Fast Track status from the US Food and Drug Administration (FDA). In Phase II trials, COVID-19 patients with marked/severe breathlessness demonstrated a threefold chance of recovery when treated with SNG001 versus placebo. For more detailed information, please see the notes below.

Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com

COVID-19

COVID-19, caused by the SARS-CoV-2 virus, is an ongoing global pandemic and there is widespread recognition of the urgent need for antiviral therapies, alongside vaccination programs, both for this and future pandemics. Such therapies could be used to prevent and effectively treat the severe lower respiratory tract illness that can occur with these types of diseases.

SNG001 (inhaled Interferon beta) applicability to COVID-19

Interferon beta (‘IFN-beta’) is a naturally-occurring protein, which orchestrates the body’s antiviral responses. It is used widely in the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in ‘at-risk’ patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections.

Viruses, including coronaviruses such as SARS-CoV-2, have evolved mechanisms which suppress endogenous IFN-beta production, helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication, potentially reducing the severity of infection and accelerating recovery.

Synairgen’s SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. It is [pH neutral, and is free of mannitol, arginine and human serum albumin, making it] suitable for inhaled delivery direct to the site of action. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date. SNG001 has the potential to address the urgent need for antiviral therapies for COVID-19 and for future pandemic respiratory infections, alongside vaccination programmes.

In July 2020, Synairgen announced the results of its Phase II double-blind, placebo-controlled study of 101 randomised COVID-19 hospitalised patients, which showed that SNG001 given for 14 days was associated with greater odds of improvement versus placebo on the WHO Ordinal Scale for Clinical Improvement (OSCI) and more rapid recovery to the point where patients were no longer limited in their activity, with a greater proportion of patients recovering during the 28-day study period.

The results were published in The Lancet Respiratory Medicine: “Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial”. Monk, P D PhD, et al., 12 November 2020, accessible here.

The Company’s global Phase III trial (SG018) evaluating SNG001 for the treatment of hospitalised COVID-19 patients is ongoing. The trial is deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). In the US, SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). The Company is seeking further equivalent prioritisations and support from governments in participating countries.

About Southampton Clinical Trials Unit

The Southampton Clinical Trials Unit (CTU) is a National Institute for Health Research (NIHR) supported CTU with expertise in the design, conduct and analysis of interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. (www.southampton.ac.uk/ctu/index.page) 

NEW YORK
a
nd MAINZ,
GERMANY
,
April
30
,
202
1
(GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY^® (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide.

This submission is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine also was generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

AUTHORIZED USE IN THE EU:

COMIRNATY

^®

▼ (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY^®, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.

IMPORTANT SAFETY INFORMATION:

• Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
• The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY^® may be lower in immunosuppressed individuals.
• As with any vaccine, vaccination with COMIRNATY^® may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
• In clinical studies, adverse reactions in participants 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
• There is limited experience with use of COMIRNATY^® in pregnant women. Administration of COMIRNATY^® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
• It is unknown whether COMIRNATY^® is excreted in human milk.
• Interactions with other medicinal products or concomitant administration of COMIRNATY^® with other vaccines has not been studied.
• For complete information on the safety of COMIRNATY^® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.

The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email [email protected], telephone +49 6131 9084 0, or via the website www.biontech.de.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of April 30, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and COMIRNATY^®, the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the potential of BNT162b2 for adolescents 12 to 15 years of age, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the topline data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data (including the topline data outlined in this release); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the topline data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the topline data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

BioNTech Forward-looking Statements

This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 (COMIRNATY^®) in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf-life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Pfizer Contacts:

Media Relations

Andy Widger
+44 (0)1737 330909
[email protected]

Investor Relations
Chuck Triano
+1 (212) 733-3901
[email protected]

BioNTech Contacts:

Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de

Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
[email protected]

SOUTH SAN FRANCISCO, Calif., April 30, 2021 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, today announced that the Company’s first quarter 2021 financial results will be released on Thursday, May 6, 2021. Company management will host a conference call on Thursday, May 6, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 2073385. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

About Calithera

Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.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. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of Calithera’s product candidates, the overall advancement of Calithera’s product candidates in clinical trials, the unmet need in the treatment of patients with advanced disease, and Calithera’s plans to continue development of its product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

SOURCE: Calithera Biosciences, Incorporated

CONTACT:

Stephanie Wong

[email protected]

650-870-1063

NEW YORK, April 30, 2021 (GLOBE NEWSWIRE) — Apollo Global Management, Inc. (NYSE: APO) (together with its consolidated subsidiaries, “Apollo” or the “Firm”) announced that certain funds managed by its affiliates have committed to invest $600 million as part of an agreement in which Standard Industries Holdings Inc. will acquire W.R. Grace & Co. (“Grace”) (NYSE: GRA), a leading global specialty chemicals company, in an all-cash transaction valued at approximately $7.0 billion.

Standard Industries Holdings opted to work with Apollo’s Hybrid Value business as a capital partner given Apollo’s long-standing and successful track record investing in the chemicals sector and its ability to move expeditiously to complete its due diligence and provide a bespoke investment.

“We are thrilled to support Standard Industries’ acquisition of Grace, which is a market leader that is well positioned for long-term growth as part of the Standard Industries family,” said Sam Feinstein, Apollo Private Equity Partner. “Standard Industries has a well-deserved reputation of being responsible owners of industrial assets and we believe Grace, a world-class specialty chemicals company, will enter an exciting new chapter of innovation as part of their portfolio.”

Apollo Hybrid Value Partner Valay Shah said, “This investment is another example of how Apollo’s Hybrid Value business works constructively with companies and sponsors to deliver customized capital investments on an expedited time frame.”

Apollo’s $10 billion Hybrid Value business is led by Co-Heads and Senior Partners Matt Michelini and Rob Ruberton and provides flexible capital to private and public companies seeking tailored solutions and strategic advice through structured equity and credit investments. The investment in connection with Standard Industries Holdings’ acquisition of Grace is the latest commitment by Hybrid Value, which has been highly active over the last year, leading over $6.5 billion in investments in market-leading companies across a variety of industries, including US Acute Care Solutions, Sazka, Alorica, Albertsons, Expedia and Cimpress.

Closing of the transaction between Standard Industries Holdings and Grace is subject to satisfaction of customary closing conditions, including approval by Grace shareholders and receipt of certain regulatory approvals. More details on the transaction can be found in the official announcement.

About Apollo

Apollo is a leading global investment manager with offices in New York, Los Angeles, San Diego, Houston, Bethesda, London, Frankfurt, Madrid, Luxembourg, Mumbai, Delhi, Singapore, Hong Kong, Shanghai and Tokyo, among others. Apollo had assets under management of approximately $455 billion as of December 31, 2020 in credit, private equity and real assets funds. For more information about Apollo, please visit www.apollo.com.

About Standard Industries Holdings

Standard Industries Holdings is the parent company of Standard Industries, a privately-held global industrial company operating in over 80 countries with over 15,000 employees. The Standard ecosystem spans a broad array of holdings, technologies and investments—including both public and private companies from early to late-stage—as well as world-class building materials assets and next-generation solar solutions. Throughout its 140-year history, Standard has leveraged its deep industry expertise and vision to create outsize value across its businesses, which today include operating companies GAF, BMI, Siplast, GAF Energy, Schiedel and SGI, as well as related businesses 40 North, a multi-billion-dollar investment platform, 40 North Ventures and Winter Properties. Learn more at www.standardindustries.com.

Investor Contact:

Peter Mintzberg
Head of Investor Relations
Apollo Global Management, Inc.
(212) 822-0528
[email protected]

Media Contact:

Joanna Rose
Global Head of Corporate Communications
Apollo Global Management, Inc.
(212) 822-0491
[email protected]

NEW HAMPTON, N.Y., April 30, 2021 (GLOBE NEWSWIRE) — Balchem Corporation (NASDAQ: BCPC) reported today first quarter 2021 net earnings of $23.4 million, compared to net earnings of $19.8 million for the first quarter 2020, adjusted net earnings^(a) of $28.4 million, compared to $26.4 million in the prior year quarter, and adjusted EBITDA^(a) of $45.7 million, compared to $42.4 million in the prior year quarter.

First Quarter 2021 Financial Highlights:

• Net sales were $185.7 million, an increase of $11.2 million, or 6.4%, compared to the prior year quarter, with year over year sales growth in all three segments: Human Nutrition and Health, Animal Nutrition and Health, and Specialty Products.
• Adjusted EBITDA was $45.7 million, an increase of $3.4 million, or 7.9%, from the prior year.
• GAAP net earnings were $23.4 million, an increase of $3.6 million, or 18.4%, from the prior year. These net earnings resulted in GAAP earnings per share of $0.72.
• Adjusted net earnings were $28.4 million, an increase of $2.0 million, or 7.6%, from the prior year. These adjusted net earnings resulted in adjusted earnings per share^(a) of $0.87.
• The effective tax rate of 21.9% was 264 basis points higher than the prior year tax rate of 19.3%.
• Cash flows from operations were $40.6 million, an increase of $18.0 million from the prior year, with quarterly free cash flow^(a) of $34.4 million compared to $17.4 million for the prior year quarter.

Recent Highlights:

• Balchem proudly signed the CEO Action for Diversity & Inclusion™ pledge as a further commitment to advance diversity and inclusion within our workplace. The CEO pledge outlines a specific set of actions the signatory CEOs will take to cultivate a trusting environment where all ideas are welcomed and employees feel comfortable and empowered to have discussions about diversity and inclusion.
• Strong cash flows in the first quarter enabled the company to make net repayments on its revolving debt of $10.0 million, lowering net debt to $65.0 million, with an overall leverage ratio on a net debt basis of 0.4.
• Successfully added another manufacturing facility onto our new ERP system during the first quarter of 2021. Approximately 96% of revenue is now on the new system and we expect to complete full implementation of the project this year.
• The COVID-19 response has continued to require attention year to date with our focus on employee safety first, keeping our manufacturing sites operational, satisfying customer needs, preserving cash and ensuring strong liquidity, and responding to changes in this dynamic market environment as appropriate.

Ted Harris, Chairman, CEO, and President of Balchem said, “We have continued the strong momentum from 2020 into the first quarter of 2021, delivering all-time record quarterly sales, net earnings, earnings per share, and adjusted EBITDA.”

Mr. Harris added, “We are very pleased to deliver sales growth in all three of our business segments, not only versus the prior year’s quarter, but also sequentially versus the fourth quarter 2020, reflecting a modest but gradual re-opening of economies around the world.”

Results for Period Ended March 31, 2021 (unaudited)

(Dollars in thousands, except per share data)

		Three Months Ended March 31,
		2021				2020
Net sales		$	185,656			$	174,436
Gross margin		58,727				55,331
Operating expenses		28,152				29,053
Earnings from operations		30,575				26,278
Other expense		592				1,788
Earnings before income tax expense		29,983				24,490
Income tax expense		6,572				4,722
Net earnings		$	23,411			$	19,768
Diluted net earnings per common share		$	0.72			$	0.61
Adjusted EBITDA(a)		$	45,724			$	42,371
Adjusted net earnings(a)		$	28,447			$	26,441
Diluted adjusted net earnings per common share(a)		$	0.87			$	0.81
Shares used in the calculations of diluted net earnings per common share and diluted adjusted net earnings per common share		32,657				32,517

(a)	See “Non-GAAP Financial Information” for a reconciliation of GAAP and non-GAAP financial measures.

Financial Results for the First Quarter of 2021:

The Human Nutrition & Health segment generated all-time record quarterly sales of $104.5 million, an increase of $9.0 million or 9.4% compared to the prior year quarter. The increase was driven both by strong sales growth of chelated minerals and choline nutrients, as well as higher sales within food and beverage markets. This segment generated all-time record quarterly earnings from operations of $19.7 million, an increase of $7.6 million or 62.3% compared to $12.1 million in the prior year quarter, primarily due to the aforementioned higher sales, product mix, and manufacturing efficiencies, partially offset by higher raw material costs. Excluding the effect of non-cash expense associated with amortization of acquired intangible assets of $4.4 million and $4.8 million for the first quarter of 2021 and 2020, respectively, all-time record adjusted earnings from operations^(a) for this segment were $24.0 million, compared to $17.2 million in the prior year quarter.

The Animal Nutrition & Health segment generated all-time record quarterly sales of $51.1 million, an increase of $2.5 million or 5.2% compared to the prior year quarter. The increase was primarily the result of higher sales in both Monogastric and Ruminant animal markets and a favorable impact related to changes in foreign currency exchange rates. First quarter earnings from operations for this segment of $5.1 million decreased $3.0 million or 37.1% compared to $8.0 million in the prior year quarter, primarily due to increases in raw material costs and distribution costs, along with an unfavorable mix. Excluding the effect of non-cash expense associated with amortization of acquired intangible assets of $0.2 million in the first quarters of 2021 and 2020, adjusted earnings from operations for this segment were $5.2 million, compared to $8.2 million in the prior year quarter.

The Specialty Products segment generated sales of $28.0 million for the quarter ended March 31, 2021, up very slightly from the same quarter in 2020, primarily due to higher sales of products for the medical device sterilization market and a favorable impact related to changes in foreign currency exchange rates, offset by lower sales in the plant nutrition business. First quarter earnings from operations for this segment were $7.2 million, versus $8.0 million in the prior year comparable quarter, a decrease of $0.8 million or 10.0%, primarily due to increases in raw material costs and distribution costs. Excluding the effect of non-cash expense associated with amortization of acquired intangible assets for the first quarter of 2021 and 2020 of $1.4 million and $1.6 million, respectively, adjusted earnings from operations for this segment were $8.6 million, compared to $9.6 million in the prior year quarter.

All-time record consolidated gross margin for the quarter ended March 31, 2021 of $58.7 million increased by $3.4 million or 6.1%, compared to $55.3 million for the prior year comparable period. Gross margin as a percentage of sales was 31.6% as compared to 31.7% in the prior year period, a decrease of 9 basis points, primarily due to a significant increase in certain raw material and distribution costs, partially offset by favorable mix and manufacturing efficiencies. Operating expenses of $28.2 million for the quarter decreased $0.9 million from the prior year comparable quarter, principally due to a decrease in transaction and integration costs, travel, bad debt expense, and amortization, partially offset by certain higher compensation-related costs. Excluding non-cash operating expenses associated with amortization of intangible assets of $6.0 million, operating expenses were $22.1 million, or 11.9% of sales.

Interest expense was $0.7 million in the first quarter of 2021. Our effective tax rates for the three months ended March 31, 2021 and 2020 were 21.9% and 19.3%, respectively. The increase in the effective tax rate from the prior year was primarily due to a reduction in certain tax credits and higher enacted tax rates in several states within the United States.

For the quarter ended March 31, 2021, cash flows provided by operating activities were $40.6 million, and free cash flow was $34.4 million. The $192.4 million of net working capital on March 31, 2021 included a cash balance of $88.5 million, which reflects a first quarter 2021 dividend payment of $18.7 million, net repayments of the revolving debt of $10.0 million, and capital expenditures and intangible assets acquired of $6.3 million.

Ted Harris said, “The first quarter of 2021 was an excellent quarter for Balchem. We faced new macro-economic challenges in the latest quarter, particularly from significantly higher raw material and distribution costs as well as complexities associated with logistical disruptions. But we stepped up to meet these challenges and the strong financial results we delivered in the first quarter once again reflect the resilience of both our team of employees and our business model.”

Mr. Harris went on to add, “I am also very proud to have recently signed the CEO Action for Diversity & Inclusion™ pledge as we continue to advance our diversity and inclusion initiatives. Signing the pledge is another important step in our continuous improvement journey relative to all of our social, environmental, and governance responsibilities.”

Quarterly Conference Call

A quarterly conference call will be held on Friday, April 30, 2021, at 11:00 AM Eastern Time (ET) to review first quarter 2021 results. Ted Harris, Chairman of the Board, CEO and President, and Martin Bengtsson, CFO, will host the call. We invite you to listen to the conference by calling toll-free 1-877-407-8289 (local dial-in 1-201-689-8341) five minutes prior to the scheduled start time of the conference call. The conference call will be available for replay two hours after the conclusion of the call through end of day Friday, May 14, 2021. To access the replay of the conference call, dial 1-877-660-6853 (local dial-in 1-201-612-7415), and use conference ID #13718858.

Segment Information

Balchem Corporation reports three business segments: Human Nutrition & Health, Animal Nutrition & Health, and Specialty Products. The Human Nutrition & Health segment delivers customized food and beverage ingredient systems, as well as key nutrients into a variety of applications across the food, supplement and pharmaceutical industries. The Animal Nutrition & Health segment manufactures and supplies products to numerous animal health markets. Through Specialty Products, Balchem provides specialty-packaged chemicals for use in healthcare and other industries, and also provides chelated minerals to the micronutrient agricultural market. Sales and production of products outside of our reportable segments and other minor business activities are included in “Other and Unallocated”.

Forward-Looking Statements

This release contains forward-looking statements, which reflect Balchem’s expectation or belief concerning future events that involve risks and uncertainties. Balchem can give no assurance that the expectations reflected in forward-looking statements will prove correct and various factors could cause results to differ materially from Balchem’s expectations, including risks and factors identified in Balchem’s annual report on Form 10-K for the year ended December 31, 2020. Forward-looking statements are qualified in their entirety by the above cautionary statement. Balchem assumes no duty to update its outlook or other forward-looking statements as of any future date.

Contact: Danielle Polanco, Balchem Corporation (Telephone: 845-326-5600)

Selected Financial Data (unaudited)

($ in 000’s)

Business Segment Net Sales:		Three Months Ended March 31,
		2021				2020
Human Nutrition & Health		$	104,516			$	95,508
Animal Nutrition & Health		51,148				48,641
Specialty Products		28,008				27,996
Other and Unallocated (1)		1,984				2,291
Total		$	185,656			$	174,436

Business Segment Earnings Before Income Taxes:		Three Months Ended March 31,
		2021				2020
Human Nutrition & Health		$	19,690			$	12,135
Animal Nutrition & Health		5,056				8,044
Specialty Products		7,189				7,986
Other and Unallocated (1)		(1,360		)		(1,887		)
Interest and other expense		(592		)		(1,788		)
Total		$	29,983			$	24,490
(1) Other and Unallocated consists of a few minor businesses which individually do not meet the quantitative thresholds for separate presentation and corporate expenses that have not been allocated to a segment. Unallocated corporate expenses consist of: (i) Transaction and integration costs, ERP implementation costs, and unallocated legal fees totaling $234 and $1,272 for the three months ended March 31, 2021 and 2020 (refer to note 4 for descriptions of these charges), respectively, and (ii) Unallocated amortization expense of $604 and $401 for the three months ended March 31, 2021 and 2020, respectively, related to an intangible asset in connection with a company-wide ERP system implementation.

Selected Balance Sheet Items
(Dollars in thousands)		(unaudited)
		March 31, 2021				December 31, 2020
Cash and Cash Equivalents		$	88,535			$	84,571
Accounts Receivable, net		106,806				98,214
Inventories		77,022				70,620
Other Current Assets		8,841				13,483
Total Current Assets		281,204				266,888
Property, Plant & Equipment, net		226,513				228,096
Goodwill		526,246				529,463
Intangible Assets with Finite Lives, net		113,659				121,660
Right of Use Assets		8,708				8,410
Other Assets		12,885				11,326
Total Assets		$	1,169,215			$	1,165,843
Current Liabilities		$	88,763			$	94,428
Revolving Loan		153,569				163,569
Deferred Income Taxes		51,865				51,359
Derivative Liabilities		6,758				11,658
Long-Term Obligations		18,768				16,596
Total Liabilities		319,723				337,610
Stockholders’ Equity		849,492				828,233
Total Liabilities and Stockholders’ Equity		$	1,169,215			$	1,165,843

Balchem Corporation

Condensed Consolidated Statements of Cash Flows

(Dollars in thousands)

(unaudited)

		Three Months Ended March 31,
		2021				2020
Cash flows from operating activities:
Net earnings		$	23,411			$	19,768
Adjustments to reconcile net earnings to net cash provided by operating activities:
Depreciation and amortization		12,364				12,549
Stock compensation expense		2,622				2,181
Other adjustments		(161		)		634
Changes in assets and liabilities		2,371				(12,567		)
Net cash provided by operating activities		40,607				22,565
Cash flows from investing activities:
Capital expenditures and intangible assets acquired		(6,312		)		(5,394		)
Proceeds from insurance and sale of assets		86				—
Net cash used in investing activities		(6,226		)		(5,394		)
Cash flows from financing activities:
Proceeds from revolving loan		5,000				10,000
Principal payments on revolving loan		(15,000		)		(5,000		)
Principal payments on finance lease		(39		)		—
Proceeds from stock options exercised		2,402				4,435
Dividends paid		(18,700		)		(16,704		)
Purchase of treasury stock		(1,596		)		(891		)
Net cash used in financing activities		(27,933		)		(8,160		)
Effect of exchange rate changes on cash		(2,484		)		(724		)
Increase in cash and cash equivalents		3,964				8,287
Cash and cash equivalents, beginning of period		84,571				65,672
Cash and cash equivalents, end of period		$	88,535			$	73,959

Non-GAAP Financial Information

In addition to disclosing financial results in accordance with United States (U.S.) generally accepted accounting principles (GAAP), this earnings release contains non-GAAP financial measures that we believe are helpful in understanding and comparing our past financial performance and our future results. The non-GAAP financial measures disclosed by the company exclude certain business combination accounting adjustments and certain other items related to acquisitions, certain unallocated equity compensation, and certain one-time or unusual transactions. These non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and the financial results calculated in accordance with GAAP and reconciliations from these results should be carefully evaluated. Management believes that these non-GAAP measures provide useful information about the Company’s core operating results and thus are appropriate to enhance the overall understanding of the Company’s past financial performance and its prospects for the future. The non-GAAP financial measures in this press release include adjusted gross margin, adjusted earnings from operations, adjusted net earnings and the related adjusted per diluted share amounts, EBITDA, adjusted EBITDA, adjusted income tax expense, and free cash flow. EBITDA is defined as earnings before interest, other expense/income, taxes, depreciation and amortization. Adjusted EBITDA is defined as earnings before interest, other expense/income, taxes, depreciation, amortization, stock-based compensation, transaction and integration costs, indemnification settlements, legal settlements, ERP implementation costs, unallocated legal fees, the fair valuation of acquired inventory, goodwill impairment, and restructuring costs. Adjusted income tax expense is defined as income tax expense adjusted for the impact of ASU 2016-09. Free cash flow is defined as net cash provided by operating activities less capital expenditures and capitalized ERP implementation costs.

Set forth below are reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures.

Table 1

Reconciliation of Non-GAAP Measures to GAAP

(Dollars in thousands, except per share data)

(unaudited)

		Three Months Ended March 31,
		2021				2020
Reconciliation of adjusted gross margin
GAAP gross margin		$	58,727			$	55,331
Inventory valuation adjustment (2)		—				208
Amortization of intangible assets and finance lease (3)		489				724
Adjusted gross margin		$	59,216			$	56,263
Reconciliation of adjusted earnings from operations
GAAP earnings from operations		$	30,575			$	26,278
Inventory valuation adjustment (2)		—				208
Amortization of intangible assets and finance lease (3)		6,536				6,979
Transaction and integration costs, ERP implementation costs, and unallocated legal fees (4)		234				1,272
Adjusted earnings from operations		$	37,345			$	34,737
Reconciliation of adjusted net earnings
GAAP net earnings		$	23,411			$	19,768
Inventory valuation adjustment (2)		—				208
Amortization of intangible assets and finance lease (3)		6,607				7,049
Transaction and integration costs, ERP implementation costs, and unallocated legal fees (4)		234				1,272
Income tax adjustment (5)		(1,805		)		(1,856		)
Adjusted net earnings		$	28,447			$	26,441
Adjusted net earnings per common share – diluted		$	0.87			$	0.81

The following table sets forth a reconciliation of Net Earnings calculated using amounts determined in accordance with GAAP to EBITDA and to Adjusted EBITDA for the three months ended March 31, 2021 and 2020.

Table 2

(unaudited)

		Three Months Ended March 31,
		2021				2020
Net earnings – as reported		$	23,411			$	19,768
Add back:
Provision for income taxes		6,572				4,722
Other expense		592				1,788
Depreciation and amortization		12,293				12,479
EBITDA		42,868				38,757
Add back certain items:
Non-cash compensation expense related to equity awards		2,622				2,134
Inventory valuation adjustment (2)		—				208
Transaction and integration costs, ERP implementation costs, and unallocated legal fees (4)		234				1,272
Adjusted EBITDA		$	45,724			$	42,371

The following table sets forth a reconciliation of our GAAP effective income tax rate to our non-GAAP effective income tax rate for the three months ended March 31, 2021 and 2020.

Table 3

(unaudited)

		Three Months Ended March 31,
		2021				Effective Tax Rate			2020				Effective Tax Rate
GAAP Income Tax Expense		$	6,572			21.9	%		$	4,722			19.3	%
Impact of ASU 2016-09 (6)		249							157
Adjusted Income Tax Expense		$	6,821			22.7	%		$	4,879			19.9	%

The following table sets forth a reconciliation of net cash provided by operating activities to free cash flow for the three months ended March 31, 2021 and 2020.

Table 4

(unaudited)

		Three Months Ended March 31,
		2021					2020
Net cash provided by operating activities		$	40,607				$	22,565
Capital expenditures and capitalized ERP implementation costs		(6,175		)			(5,152		)
Free cash flow		$	34,432				$	17,413

(2) Inventory valuation adjustment: Business combination accounting principles require us to measure acquired inventory at fair value. The fair value of inventory reflects the acquired company’s cost of manufacturing plus a portion of the expected profit margin. The non-GAAP adjustment to our cost of sales excludes the expected profit margin component that is recorded under business combination accounting principles. We believe the adjustment is useful to investors as an additional means to reflect cost of sales and gross margin trends of our business.

(3) Amortization of intangible assets and finance lease: Amortization of intangible assets and finance lease consists of amortization of customer relationships, trademarks and trade names, developed technology, regulatory registration costs, patents and trade secrets, capitalized loan issuance costs, other intangibles acquired primarily in connection with business combinations, an intangible asset in connection with a company-wide ERP system implementation, and one finance lease. We record expense relating to the amortization of these intangibles and finance lease in our GAAP financial statements. Amortization expenses for our intangible assets and finance lease are inconsistent in amount and are significantly impacted by the timing and valuation of an acquisition. Consequently, our non-GAAP adjustments exclude these expenses to facilitate an evaluation of our current operating performance and comparisons to our past operating performance.

(4) Transaction and integration costs, ERP implementation costs and unallocated legal fees: Transaction and integration costs related to acquisitions and divestitures are expensed in our GAAP financial statements. ERP implementation costs related to a company-wide ERP system implementation are expensed in our GAAP financial statements. Unallocated legal fees for transaction-related non-compete agreement disputes are expensed in our GAAP financial statements. Management excludes these items for the purposes of calculating Adjusted EBITDA and other non-GAAP financial measures. We believe that excluding these items from our non-GAAP financial measures is useful to investors because these are items associated with each transaction and are inconsistent in amount and frequency causing comparison of current and historical financial results to be difficult.

(5) Income tax adjustment: For purposes of calculating adjusted net earnings and adjusted diluted earnings per share, we adjust the provision for (benefit from) income taxes to tax effect the taxable and deductible non-GAAP adjustments described above as they have a significant impact on our income tax (benefit) provision. Additionally, the income tax adjustment is adjusted for the impact of adopting ASU 2016-09, “Improvements to Employee Share-Based Payment Accounting” and uses our non-GAAP effective rate applied to both our GAAP earnings before income tax expense and non-GAAP adjustments described above. See Table 3 for the calculation of our non-GAAP effective tax rate.

(6) Impact of ASU 2016-09: The primary impact of ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”), was the recognition during the three months ended March 31, 2021 and 2020, of excess tax benefits as a reduction to the provision for income taxes and the classification of these excess tax benefits in operating activities in the consolidated statement of cash flows instead of financing activities.

SALT LAKE CITY, April 30, 2021 (GLOBE NEWSWIRE) — Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative disease using bioenergetic nanocatalysis, today announced the U.S. Patent and Trademark Office has issued Notices of Allowance for two important patent applications covering device and process claims for its platform technology and advanced stage clean-surfaced nanocrystal therapeutic candidates.

The first allowed application titled “Continuous Methods for Treating Liquids and Manufacturing Certain Constituents (e.g., Nanoparticles) in Liquids, Apparatuses and Nanoparticles and Nanoparticle/Liquid Solution(s) Resulting Therefrom” covers a broad set of device claims pertaining to Clene’s platform electrochemical technology for making solutions and suspensions.

Additionally, very broad process claims for forming nanocrystals (such as gold), in liquids, is covered in the second allowed application titled “Continuous, Semicontinuous and Batch Methods for Treating Liquids and Manufacturing Certain Constituents (e.g., Nanoparticles) in Liquids, Apparatuses and Nanoparticles and Nanoparticle/Liquid Solution(s) and Colloids Resulting Therefrom.”

Both patents, once issued, will continue to provide important intellectual property protection for CNM-Au8, Clene’s lead drug candidate. CNM-Au8 is now being evaluated across seven clinical studies for the treatment of amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease including a Phase 3 registration trial in ALS for which results are expected in the first half of 2022.

“Our leadership position in clean-surfaced nanocrystal therapeutics is fortified by our growing patent estate. These IP assets become increasingly valuable as our clinical pipeline advances, and as CNM-Au8 nears completion of its pivotal Phase 3 trial and potential commercialization,” stated Rob Etherington, President and CEO of Clene.

Clene’s worldwide patent portfolio in the new field of clean-surfaced nanocrystal therapeutics now includes over 130 patents issued and allowed, with around 30 more applications pending. The issued patents cover state of matter claims for suspensions and solutions, as well as processes for making the materials, devices for conducting the unique electro-crystal chemistry processes, and methods of using the novel materials.

About CNM-Au8

Clene’s lead drug candidate, CNM-Au8, a bioenergetic nanocatalyst, is a stable, aqueous suspension of catalytically active gold (Au) nanocrystals. In a patented breakthrough, clean surfaced nanocrystalline CNM-Au8 drives critical cellular bioenergetic reactions in the brain to increase cellular energy, accelerate neurorepair, and improve neuroprotection. CNM-Au8 crosses the blood-brain barrier and is not associated with the toxicities related to synthetic gold compounds or nanoparticles manufactured via synthetic chemistry. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial examining disease progression via a novel electromyography technique in patients with early ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and Phase 2 brain target engagement studies in patients with Parkinson’s disease (PD) and MS. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and has shown both remyelination and neuroprotective effects in multiple preclinical (animal) models. Preclinical data, both published in peer-reviewed journals and presented at scientific congresses, demonstrate that treatment of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular levels of reactive oxygen species and improves mitochondrial capacity in response to cellular stresses induced by multiple disease-relevant neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors in rodent models of ALS, MS, and PD versus vehicle (placebo).

About Clene

Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease, is leading the way by using nanotechnology to treat bioenergetic failure, which underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs—bioenergetic nanocatalysts. Clene’s lead drug candidate, CNM-Au8, is a concentrated nanocrystalline gold (Au) suspension that drives critical cellular bioenergetic reactions in the CNS. CNM-Au8 increases cellular energy to accelerate neurorepair and improve neuroprotection. Currently, CNM-Au8 is being investigated for efficacy and safety in a Phase 3 registration trial for ALS and in Phase 2 trials for multiple sclerosis and Parkinson’s disease. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Clene’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “might” and “continues,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene’s control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene’s reliance on third parties to conduct drug development, manufacturing and other services; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in Clene’s Annual Report filed on Form 10K, as well as discussions of potential risks, uncertainties, and other important factors in Clene’s subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

Media Contact

Andrew Mielach
LifeSci Communications
(646) 876-5868
[email protected]

Investor Contact

Bruce Mackle
LifeSci Advisors, LLC
(929) 469-3859
[email protected]

Source: Clene Inc.