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Research: Healthcare
Part A of the AD-214 Phase I has been completed in 42 healthy volunteers who received a single dose of either AD-214 or placebo. There were no dose limiting or serious adverse events and no concerning clinical laboratory results. Additionally, AD-214 pharmacokinetics increased proportionally with the dose with evidence seen of CXCR4 engagement and high sustained receptor occupancy. AdAlta will now be investigating dosing every two weeks for AD-214 in the Part B portion of the study.
Written by
AdAlta |
Preliminary Part A results |
Development update |
Pharma & biotech |
15 March 2021 |
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Business description
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AdAlta is a research client of Edison Investment Research Limited |
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Part A of the AD-214 Phase I has been completed in 42 healthy volunteers who received a single dose of either AD-214 or placebo. There were no dose limiting or serious adverse events and no concerning clinical laboratory results. Additionally, AD-214 pharmacokinetics increased proportionally with the dose with evidence seen of CXCR4 engagement and high sustained receptor occupancy. AdAlta will now be investigating dosing every two weeks for AD-214 in the Part B portion of the study.
Year end |
Revenue (A$m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/19 |
3.5 |
(5.9) |
(0.05) |
0.0 |
N/A |
N/A |
06/20 |
3.8 |
(5.9) |
(0.04) |
0.0 |
N/A |
N/A |
06/21e |
3.2 |
(6.1) |
(0.02) |
0.0 |
N/A |
N/A |
06/22e |
3.3 |
(6.2) |
(0.02) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Remainder of Phase I programme redesigned
Following the Part A results, AdAlta has redesigned the remainder of the Phase I programme, forgoing a single ascending dose study in interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) patients in favour of a multiple ascending dose (MAD) study in healthy volunteers (Part B) and a concurrently run (starting in Q3 CY21) separate Phase Ib in patients with IPF/ILD and other fibrotic diseases.
Phase II IND-ready data package as early as H1 CY22
Part B of the redesigned Phase I will be a blinded, placebo-controlled MAD study in 12–24 patients dosed at 5–15mg/kg every two weeks. This data should be available as early as H1 CY22 and will enable an IND filing to begin the Phase II programme. Additionally, this safety package would cover all intravenous indications for AD-214.
A busy remainder to CY21
Besides progressing through the Phase I programme, AdAlta is currently also expecting GE Healthcare to commence pre-clinical development of an i-body against granzyme B, a known marker of T-cell activation, in Q2 CY21. Additionally, the company is expecting a second external partnership to be announced, around the middle of the year, and two new internal targets in discovery.
Valuation: A$70m or A$0.29 per basic share
We have increased our valuation for AdAlta to A$70m (or A$0.29 per share), from A$60m (or A$0.25 per basic share) previously, due to an increase in the probability of success for AD-214 from 12.5% to 15% following the release of the preliminary Part A data and our increased confidence that the programme will progress. Note that we only attribute value to AD-214 as it is the only programme in human clinical trials, though this could change once trials in additional indications are commenced. The company had A$8.1m in cash at 31 December 2020 and we estimate will likely need to raise an additional A$11m through the end of FY23, barring additional licensing deals.
AD-214 trial update
AdAlta recently announced preliminary results from Part A of the Phase I programme for AD-214 n 42 healthy volunteers who received either a single dose of AD-214 or placebo. AD-214 was very well tolerated in single doses up to 20mg/kg. There were no dose limiting or serious adverse events (adverse events were mostly mild with three grade 2 adverse events) and no concerning clinical laboratory results. Additionally, AD-214 pharmacokinetics increased proportionally with the dose and there was high sustained receptor occupancy (see Exhibits 1 and 2). There was also evidence of CXCR4 engagement through transient increases of white blood cell and stem cell increases (signs of CXCR4 inhibition) as well as transient increases in SDF-1 (a natural ligand of CXCR4).
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Exhibit 1: AD-214 pharmacokinetics |
Exhibit 2: AD-214 receptor occupancy |
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Source: AdAlta |
Source: AdAlta |
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Exhibit 1: AD-214 pharmacokinetics |
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Source: AdAlta |
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Exhibit 2: AD-214 receptor occupancy |
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Source: AdAlta |
Due to these results, the company has re-designed its Phase I programme. Initially, Part A was to be followed by Part B, a single-dose study in ILD/IPF patients that was then to be followed by Part C, studying weekly dosing in ILD/IPF patients over four weeks. Now Part B will be a blinded, placebo-controlled MAD study in 12–24 healthy volunteers dosed at 5–15mg/kg every two weeks. This study should be completed by year-end CY21, with data available as early as H1 CY22, which will enable an IND filing to begin the Phase II programme. Additionally, this safety package would cover all intravenous indications for AD-214.
Concurrent with Part B, the company expects to commence a separate two-arm Phase Ib study in Q3 of CY21, which will seek to demonstrate AD-214 distribution and CXCR4 receptor occupancy in patients with fibrotic disease, as well as seeking initial indications of efficacy (which could help open the partnership window). The first arm will feature a radio-labelled version of AD-214 for positron emission tomography (PET) imaging and will have approximately 12 patients with fibrotic disease (including around six with IPF/ILD). The second arm will test a maximum of six doses of 5–10mg/kg over 18 weeks in six IPF/ILD patients with and without PET imaging. Both arms will be open-label and on top of standard of care. As a reminder, preclinical studies indicated a target human therapeutic dose of 10mg/kg given intravenously either weekly or every other week.
Valuation
We have increased our valuation for AdAlta to A$70m or A$0.29 per share, from A$60m or A$0.25 per basic share previously, due to an increase in the probability of success for AD-214 from 12.5% to 15% following the release of the preliminary Part A data and our increased confidence that the programme will progress. Note that we only attribute value to AD-214 as it is the only programme in human clinical trials, though this could change once trials in additional indications are commenced.
Exhibit 3: AdAlta valuation table
Product |
Main indication |
Status |
Probability of successful commercialisation |
Approval year |
Peak sales (A$m) |
Economics |
rNPV |
|
AD-214 |
IPF |
Phase I |
15% |
2028 |
718 |
100.0% |
62.4 |
|
Total |
|
|
|
|
|
|
62.4 |
|
Net cash (as of 31 December 2020) |
8.1 |
|||||||
Total firm value (A$) |
70 |
|||||||
Total basic shares (m) |
245.2 |
|||||||
Value per basic share (A$) |
0.29 |
|||||||
Options (m) |
30.2 |
|||||||
Total number of shares (m) |
275.4 |
|||||||
Diluted value per share (A$) |
0.26 |
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Source: Edison Investment Research
Financials
AdAlta reported A$8.1m in cash on its balance sheet at the end of December 2020. Historically, the company has had a relatively low burn rate in terms of operating cash flow, of about A$5.9m in FY20 and A$5.8m in FY19. In H1 of FY21, the burn rate was only A$0.8m, benefiting from the receipt of a A$3.1m R&D tax incentive refund for FY20. We estimate AdAlta will likely need to raise an additional A$11m through the end of FY23 (at which point AD-214 should be in the midst of Phase II testing), which we model as illustrative long-term debt, barring additional licensing deals.
Exhibit 4: Financial summary
A$000s |
2019 |
2020 |
2021e |
2022e |
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Year end 30 June |
AIFRS |
AIFRS |
AIFRS |
AIFRS |
||
PROFIT & LOSS |
||||||
Revenue |
|
|
3,539 |
3,828 |
3,244 |
3,276 |
Cost of Sales (including R&D) |
(7,354) |
(7,012) |
(7,082) |
(7,153) |
||
Gross Profit |
(3,815) |
(3,185) |
(3,838) |
(3,877) |
||
Sales, General and Administrative Expenses |
(1,315) |
(1,265) |
(1,316) |
(1,368) |
||
EBITDA |
|
|
(5,957) |
(5,798) |
(5,920) |
(6,011) |
Operating Profit (before amort. and except.) |
|
|
(5,989) |
(5,840) |
(5,961) |
(6,052) |
Intangible Amortisation |
0 |
0 |
0 |
0 |
||
Other |
(827) |
(1,348) |
(766) |
(766) |
||
Exceptionals |
20 |
(70) |
0 |
0 |
||
Operating Profit |
(5,969) |
(5,910) |
(5,961) |
(6,052) |
||
Net Interest |
51 |
(96) |
(100) |
(104) |
||
Other |
0 |
0 |
0 |
0 |
||
Profit Before Tax (norm) |
|
|
(5,938) |
(5,936) |
(6,062) |
(6,157) |
Profit Before Tax (FRS 3) |
|
|
(5,918) |
(6,006) |
(6,062) |
(6,157) |
Tax |
0 |
0 |
0 |
0 |
||
Deferred tax |
(0) |
(0) |
(0) |
(0) |
||
Profit After Tax (norm) |
(5,938) |
(5,936) |
(6,062) |
(6,157) |
||
Profit After Tax (FRS 3) |
(5,918) |
(6,006) |
(6,062) |
(6,157) |
||
Average Number of Shares Outstanding (m) |
118.4 |
164.0 |
250.0 |
252.5 |
||
EPS - normalised (c) |
|
|
(5.02) |
(3.62) |
(2.42) |
(2.44) |
EPS - Reported ($) |
|
|
(0.05) |
(0.04) |
(0.02) |
(0.02) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
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BALANCE SHEET |
||||||
Fixed Assets |
|
|
141 |
177 |
164 |
166 |
Intangible Assets |
0 |
0 |
0 |
0 |
||
Tangible Assets |
138 |
99 |
86 |
88 |
||
Other |
3 |
78 |
78 |
78 |
||
Current Assets |
|
|
9,169 |
6,731 |
6,945 |
6,466 |
Stocks |
0 |
0 |
0 |
0 |
||
Debtors |
3,613 |
3,364 |
3,364 |
3,364 |
||
Cash |
5,556 |
3,367 |
3,580 |
3,102 |
||
Other |
0 |
0 |
0 |
0 |
||
Current Liabilities |
|
|
(1,819) |
(3,205) |
(1,125) |
(1,125) |
Creditors |
(1,819) |
(1,014) |
(1,125) |
(1,125) |
||
Short term borrowings |
0 |
(2,191) |
0 |
0 |
||
Long Term Liabilities |
|
|
0 |
0 |
0 |
(5,000) |
Long term borrowings |
0 |
0 |
0 |
(5,000) |
||
Other long term liabilities |
0 |
0 |
0 |
0 |
||
Net Assets |
|
|
7,491 |
3,702 |
5,984 |
507 |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
(5,816) |
(5,889) |
(5,295) |
(5,476) |
Net Interest |
0 |
0 |
0 |
0 |
||
Tax |
0 |
0 |
0 |
0 |
||
Capex |
(171) |
(2) |
(2) |
(3) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
||
Financing |
9,237 |
1,626 |
7,796 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
||
Net Cash Flow |
3,250 |
(4,265) |
2,498 |
(5,479) |
||
Opening net debt/(cash) |
|
|
(2,306) |
(5,556) |
(1,175) |
(3,580) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
||
Exchange rate movements |
0 |
0 |
0 |
0 |
||
Other |
0 |
-116 |
-93 |
0 |
||
Closing net debt/(cash) |
|
|
(5,556) |
(1,175) |
(3,580) |
1,898 |
Source: Company reports, Edison Investment Research
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Research: Healthcare
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