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]