IIR Pharma & Biotech Index
SECTOR OVERVIEW
Welcome to the first edition of the Pharma & Biotech Newsletter
for 2021. To begin with let’s take a look at how the IIR Pharma
& Biotech Index has begun the new year. The sector started the
year fairly muted with the Index up just 0.5% in January. This
was in line with the broader market, with the ASX All Ordinaries
Accumulation Index up 0.3%.
The top 10 constituents were a drag on the index, falling 2.1% in
January. Imugene Limited (ASX: IMU) fell out of the top 10, with
Starpharma Holdings Limited (ASX: SPL) re-joining the top 10.
PME, the largest company in the index, was clearly the best
performer in the top 10 in January, with the share price increasing
25.4%. The share price was buoyed by the announcement of a
$40 million, 7-year contract with Intermountain Healthcare for
Visage to replace legacy PACS and their speciality systems across
Intermountain Healthcare’s 24 hospitals and 200+ clinics
THE BEST PERFORMERS OF 2020
We thought we’d kick off the year by taking a look at the
top performing companies in the index for 2020. The top 10
performers are tabled below. There were some impressive returns
for some of the companies in the index with 29 companies share
prices rising by 100% or more. Race Oncology Ltd was the best
performer for the year with the share price increasing 821.1%.
4DX was one of the best performers after only listing in August
2020. We note, the performance of 4DX is based on the IPO offer
Race Oncology Ltd (ASX: RAC)
RAC was the best performing stock in the IIR Pharma & Biotech
Index in 2020, with the stock price increasing 821.1% from $0.19
on 1 January 2020 to $1.75 at 31 December 2020. The positive
momentum has continued into 2021, with the share price hitting
new highs in early February.
The share price increase was driven by a number of positive
results received for the company’s lead drug candidate,
Bisantrene. In June 2020, the company announced the Phase
II clinical trials results from the use of Bisantrene in relapsed or
refractory Acute Myeloid Leukaemia (R/R AML), a disease with no
clearly established standard of care. Bisantrene was found to be
well tolerated and after only a single course of treatment had an
overall clinical response rate of 40%. Of the 10 patients treated,
one patient achieved a complete remission and three patients
achieved partial remission. The number of patients treated was
small, however, the study treated patients with R/R AML who on
average had failed three prior lines of treatment. This makes the
findings significant.
During the second half of the year, the company expanded its
strategic direction after a scientific publication showed Bisantrene
to be a potent inhibitor of Fat Mass and Obesity-associated
(FTO) protein. Research has shown the FTO protein plays a
central role in the proliferation of a wide range of cancers. This
new data has transformed the potential use of Bisantrene from
a chemotherapeutic to a targeted therapeutic agent with broad
application across oncology.
The company unveiled its Three Pillar strategy in November 2020
to unlock the potential opportunity of the use of Bisantrene as
a precision oncology target as well continuing to pursue the
opportunities of the use of Bisantrene as chemotherapeutic agent
in AML and Breast Cancer. The company is progressing with a
number of clinical trials across all three areas of opportunity. This
is definitely a company to keep an eye on in 2021
Rhythm Biosciences Limited (ASX: RHY)
The share price of RHY performed strongly over 2020, with the
large portion of the increase taking place in the second half of the
year.
RHY is a predictive cancer diagnostics technology company, the
lead product of which is “ColoSAT”, an early detection test for
colorectal cancer. ColoSTAT seeks to more accurately detect
colorectal cancer via a simple, accurate, low-cost blood test and is
aimed at global mass-market screening.
Development of ColoSTAT is progressing with preliminary results
from the prototype test-kit demonstrating superior performance
to both the market standard faecal immunochemical test and
commercially sourced biomarker test kits based on testing
undertaken by the CSRIO. In addition to completing the prototype
test-kit, the company completed a number of milestones during
2020, including: technically validating the key lead and four adjuvant
biomarkers, appointment of additional clinical trial sites, ISO13485
Quality Management System certification maintained, completed
reagent development program, appointment of global manufacturer
and bolstering the IP for ColoSTAT. In January another milestone
was reached, with the completion of the initial manufacturing of
ColoSTAT test-kits, with performance and verification testing being
completed.
RHY’s share price has continued its positive momentum in 2021.
We anticipate further progression of the development of ColoSTAT
will be a catalyst for the share price.
Cryosite Limited (ASX: CTE)
CTE finished the year trading at $0.395 per share, up from $0.053
per share at the beginning of 2020.
CTE provides supply chain logistics, management of
pharmaceutical products in clinical trials and management of
biological materials and long-term storage of cord blood and tissue
samples.
During 1H’CY20, the company focused on positioning the company
for long-term growth, spending $1 million on infrastructure and
operating improvements. This has positioned CTE to take on far
larger markets by expanding services into adjoining markets and
customers.
The company operates predominantly in the clinical trial logistics
market. This is subject to stringent international standards and
Australian government mandated compliance and licencing
requirements, creating high barriers to entry. These same
standards apply to products listed on the Register of Therapeutic
Goods, which represent a much larger market than clinical trial
logistics. The company will be seeking to expand into this market
with a focus on attracting low volume, high value, temperature
controlled, highly regulated drugs, which is CTE’s speciality.
CTE reported FY20 revenue of $8.9 million, up 12.7% on the pcp,
and NPAT of $1.5 million, a turn around from the $0.6 million loss
in FY19. The company has started off FY21 on a positive note, with
1Q’FY21 sales revenue increasing 22% and positive operating
cashflow of $248,000. At 30 September 2020, CTE had cash of
$4.1 million.
The company has experienced significant challenges over the
last few years with the share price falling from a high of $0.60
per share in October 2013 to a low of $0.03 in 2019. Given the
challenges experienced, the company is progressing with cautious
optimism with respect to generating a return on capital.
Imagion Biosystems Limited (ASX: IBX)
IBX is developing a new non-radioactive and safe diagnostic
imaging technology. Using its MagSense technology, the
company is focused on the detection of cancer and other
diseases earlier and with higher specificity than is currently
possible. The MagSense System and Test for staging HER2 breast
cancer received a Breakthrough Device designation from the FDA
in July 2019.
During 2020, the company took significant steps towards the
development of its early detection technology culminating
with the company gaining approval from the Human Research
Ethics Committee (HREC) for the MagSense Phase I clinical
study for metastatic breast cancer with enrolments for the
study commencing in December. The study will be conducted in
Australia with Monash Health being the first clinical site for the
study.
The company raised $11 million (before costs) in the 1H’FY21 to
progress development of the MagSense technology. Funds will
enable the company to accelerate development plans in parallel
with the Phase I study, including scaling up manufacturing,
product development for additional indicators, and a larger pivotal
study in the US.
Anteotech Ltd (ASX: ADO)
ADO had a breakout year in 2020 with the share price up 387.4%
and the positive momentum has continued into 2021 with the
share price hitting new 52 week highs.
In July 2020, the company announced the development of a high
sensitivity rapid antigen test for COVID-19 using the company’s
activated Europium particle technology.
The company promptly completed Proof of Concept and Design
Verification phases of development with high sensitivity achieved
in the internal Design Verification stage, the results of which were
verified by an independent study.
The company has progressed to clinical trials which will be
followed by commercialisation if the trials are successful. The
company is expecting to have the product ready for launch to the
market in 3-5 months. The company is also seeking to combine
the test to detect COVID-19 and Flu A/B from a single test.
Further progress towards commercialisation of the COVID-19
rapid antigen test is expected to act as a further catalyst for the
share price.
COMPANY NEWS
Below we look at stocks in the IIR Pharma & Biotech Index
that made notable announcements during the month that
were received well by the market. These include: Prescient
Therapeutics Limited (ASX: PTX), Nyrada Inc (ASX: NYR);
Noxopharm Limited (ASX: NOX); Antisense Therapeutics Limited
(ASX: ANP); and Rhythm Biosciences Limited (ASX: RHY).
Prescient Therapeutics Limited (ASX: PTX)
PTX performed strongly in January with the share price up
64.2%. During the month, the company announced the internal
development program for the OmniCAR platform.
The development program will focus on cancer targets for three
indications where first generation CAR-T therapies have faced
challenges and where the OmniCAR platform may improve
treatment. The program will include:
� OmniCAR CD33 and CLL-1 for Acute Myeloid Leukaemia (AML);
� OmniCAR HER2 for HER2+ solid tumours including breast,
ovarian and gastric cancers; and
� OmniCAR HER2 and EGFRviii for glioblastoma multiforme
(GBM).
The OmniCAR technology is expected to provide benefits over
current generation CAR-T therapies including: titration for improved
safety; the ability to switch antigen targeting; co-arming CAR-T
against multiple antigens simultaneously; persistent dosing; and
tumour microenvironment enhancements to improve efficacy.
The development program will move the platform towards
clinical programs in addition to demonstrating the features of the
technology to unlock future value.
Nyrada Inc. (ASX: NYR)
NYR is a drug discovery and development company specialising in
novel small molecule drugs to treat cardiovascular and neurological
diseases. The company has two main programs: (1) cholesterollowering
drug; and (2) a drug to treat brain injury, specifically
traumatic brain injury and stroke.
During the month, the company announced further results from
the NYX-PCSK9i In Vivo study. The study is seeking to evaluate
the effectiveness of the company’s PCSK9 inhibitor to lower LDLcholesterol,
a leading cause of cardiovascular disease.
The results built on the previously announced 57% reduction in
total cholesterol, showing that LDL cholesterol levels were lowered
in a dose-dependent manner. The data supports the continued
development of the drug candidate towards in-human clinical trials.
It also confirms the use of NYX-PCSK9i as a potential oral treatment
that can be combined with a statin to assist those patients that
can’t reach their targeted LDL cholesterol levels by taking a statin
alone.
The next step for the company in addition to further safety testing
is to determine the level of enhancement that can be achieved by
combining NYX-PCSK9i with statin, the most commonly prescribed
drug to lower cholesterol.
NYR plans to develop an oral medication for patients with high
cholesterol giving them a more convenient option than the current
treatment, which involves regular injections.
NYR’s share price was up 62.5% in January to close the month
trading at $0.39. This is a 95% increase on the IPO offer price of
$0.20 in January 2020.
Noxopharm Limited (ASX: NOX)
NOX’s share price continued its positive momentum in January,
with the share price up 41.8% for the month.
The market responded positively to the Shareholder Update
provided by the company. The company is progressing the
development of its lead drug candidate, Veyonda. Veyonda seeks
to be used as an adjuvant to existing cancer treatments to reduce
resistance to these treatments and allow them to be more effective
in targeting cancerous cells.
The company is currently progressing three studies with Veyonda:
� IONIC study - a Phase I/II study testing the ability of Veyonda to
boost the response to Bristol Myers Squibb’s immuno-oncology
drug, Opdivo.
� LuPIN study - a Phase II study to test the ability of Veyonda
to boost the response to Novartis’s radiopharmaceutical,
LuPSMA-617.
� DARRT-2 study - a Phase II study testing the ability of
Veyonda to achieve high rates of abscopal effect in
patients with prostate, breast or lung cancers. An abscopal
response occurs when the treatment of a targeted tumour
with radiotherapy results in the concurrent shrinkage of
non-targeted tumours.
If Veyonda is proven effective, we expect this to be a highly
valuable drug and we expect positive results from the studies
to continue to be catalysts for the share price.
Antisense Therapeutics Limited (ASX: ANP)
ANP’s share price increased 38.5% with the share price
boosted by the initiation of broker coverage.
ANP is developing ATL1102, an antisense inhibitor of the
CD49d receptor for Duchenne Muscular Dystrophy (DMD)
patients. ATL1102 has completed a Phase II efficacy and safety
trial, significantly reducing the number of brain lesions for
patients with relapsing-remitting multiple sclerosis.
In 4Q’CY2020, ATL1102 received Orphan Drug Designation
for DMD in both Europe and the US. Orphan status provides
development and marketing incentives, such as reduced fees,
scientific advice and market exclusivity for a period of time
upon regulatory approval.
In November 2020, the company dual listed on the Frankfurt
Stock Exchange in an effort to broaden the international
investor base in line with the planned clinical development of
ATL1102.
Rhythm Biosciences Limited (ASX: RHY)
RHY continued its positive momentum with the share price up
a further 34.3% in January. As discussed above, RHY was one
of the best performers in the Pharma & Biotech Index in 2020.
RHY is a predictive cancer diagnostics technology company, the
lead product of which is “ColoSAT”, an early detection test for
colorectal cancer. ColoSTAT seeks to more accurately detect
colorectal cancer via a simple, accurate, low-cost blood test and
is aimed at global mass-market screening.
During the month, RHY announced that the initial
manufacturing of the ColoSTAT test-kits had been completed
and that the clinical trial had been expanded to a 10th site.
We anticipate the continued progression of the development of
ColoSTAT will be a further catalyst for the share price.