Is Immupharma worth a punt?
“…With IMM’s stock now priced less than 3p, and the approval process – though delayed – still on the tracks, is now the time to take a stake? IMM has never been cheaper. Positive news – whenever it may come – may inject new value into a share worth 7p just a couple of months ago…”
Biopharmaceutical company ImmuPharma (AIM:IMM) has tantalised the markets this year with the prospect of US Food & Drug Administration (FDA) approval for its advanced Phase 3 Lupuzor autoimmunity treatment. The company’s share price plunged last month after the Agency requested further refinements before giving the green light. With IMM’s stock now priced less than 3p, and the approval process – though delayed – still on the tracks, is now the time to take a stake?
Autoimmunity/inflammation and anti-infective innovation
IMM is focused on two core therapeutic areas, autoimmunity/inflammation and anti-infectives. The company’s primary innovation is its ‘P140 technology platform’ developed in collaboration with the Centre National de la Recherche Scientifique, the largest fundamental research organisation in Europe. The platform has seeded IMM’s lead asset, Lupuzor, a candidate for a novel first-line drug therapy for the treatment of systemic lupus erythematosus (SLE), a chronic life-threatening autoimmune inflammatory disease with a pattern of flares and remission, affecting the skin, joints, kidneys, blood cells, the heart, lungs and other organs, and for which there is currently no cure: current drugs have serious side-effects and patchy success. Lupus affects five million people globally, opening a $2bn market for a safe and effective new treatment.
Rather than acting as an immunosuppressant like existing therapies, Lupuzor modulates the immune system, ‘normalising’ what is otherwise a hyperactive immune state. All trials to date have indicated the platform is effective, safe, well tolerated and convenient, administered through a monthly injection. Three years ago IMM secured secured a transformative agreement with US drugs company Avion Pharmaceuticals that commits Avion meeting up to $25m of the cost of funding Lupuzor’s international Phase 3 trial in return for commercial rights in the US. IMM retains rights for commercialisation across the rest of the world.
The P140 platform has seeded a second candidate, a treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a progressive inflammatory condition of the nerves similar to MS, with symptoms including fatigue, numbness, impaired reflexes, and weakness in the arms and legs. There are as yet no effective drugs for the condition, which is currently treated through intravenous methods that require lengthy hospital visits every four to six weeks. IMM’s P140 treatment, a simple monthly injection that can be self-administered at home, is at Phase 2/3 ‘adaptive trial’ stage, being finalised for regulatory submission with discussions with commercial partners underway. IMM suggests the target market is worth more than $750m.
Continued P140 research is opening possibilities for further clinical applications including asthma, Sjögrens syndrome, irritable bowel disease, periodontitis and gout. IMM has commenced work to develop ‘a pharmacologically improved version of P140, a second-generation product’ that aims to further strengthen the company’s IP position.
In addition to P140, the company is also developing two anti-infective platforms, both at pre-clinical phase. The World Health Organisation notes antibiotic and anti-fungal resistance as one of the biggest threats to global health, cost and mortality, presenting the ever-looming threat of new and resistant organisms, yet it has one of the lowest R&D spends in the biopharma industry: few significant new products or classes have been discovered or developed in recent years. BioAMB is a prospective treatment for serious and life-threatening fungal infections such as aspergillosis, a cause of serious kidney toxicity and other severe reactions, affecting some four million sufferers worldwide. BioCIN targets severe bacterial infections like sepsis and lower respiratory tract, skin, and bone infections. The treatment seeks to improve upon Vancomycin, the current last resort therapy, which is poorly absorbed from the gut and currently requires carefully controlled IV therapy over many hours. BioCIN, administered through a simple injection, is targeting a market that estimates suggests is worth more than $2bn.
IMM’s waiting game
Though IMM continues to progress its CIDP and anti-infective candidates, the company’s news this year has been dominated by its efforts to secure final FDA approval for Lupozor. The company’s shares surged in April when it announced that the results from a pharmacokinetic (PK) study required by the FDA had met the Agency’s ‘key endpoints’. As with all past trials, the study indicated P140 was well tolerated across all doses and in all subjects, and cleared the path for the commencement of Phase 3 clinical studies. In June, in ‘a pivotal moment’ for the company, IMM said its partner Avion had sought final regulatory guidance from the FDA in preparation for the start of the international Phase 3 trial of Lupuzor. But last month IMM published a somewhat anti-climatic statement, saying that the company had received a written response from the FDA, which ‘was detailed and included significant guidance on next steps for the clinical programme. This included advice on the dosing regime’. The Agency ‘provided further significant guidance on the study protocol that can be amended to improve the regulatory outcome.’
The market reacted badly, concerned that the statement indicated a further delay of unknown duration for the granting of FDA approval which might test Avion’s commitment to funding the venture. IMM’s share price nosedived from just under 7p to 3p in less than a fortnight, pushing the company’s market cap below £10m. In a subsequent update later in the month IMM shed more light on the nature of the FDA’s response, stating that the Agency had ‘recommended assessing the potential to use higher dosing in the next clinical program of Lupuzor in Lupus, to optimise the clinical benefit to Lupus patients and to maximise efficacy.’ The Agency had also ‘made additional recommendations on clinical measurements’. IMM CEO Tim McCarthy recognised ‘shareholders’ frustrations on what is a very complex regulatory process, which is having an impact on moving Lupuzor forward.’ He said the company was ‘working very closely with the clinical and regulatory teams at Avion to accommodate the FDA’s recommendations and decide on the next steps.’
IMM’s value has also been impacted somewhat by an August placing that brought in £1.1m to allow the company ‘to further invest in the other parts of our product portfolio’. IMM’s most recent interim report, reporting on the period to 30 June prior to the fundraise, stated a cash balance of £0.2m, down on £4.2m for the previous year, owing to ‘research and development expenditure related to PK study’. The operating loss for the period was £1.7m (£3.1m for the previous year).
It would be an overstatement, perhaps, to say that the FDA’s response has left IMM in limbo, but the company is in an transitional period, unable to move ahead with the Lupuzor’s international Phase 3 clinical trial until final guidance from the Agency is received. The company has emphasised its continued commitment to pressing ahead with other work, including the licensing of Lupuzor in key territories outside of the US, progressing its CIDP P140 asset, which is ‘now gaining interest from potential partners’, and advancing its pre-clinical anti-infective candidates.
Understandably, however, Lupuzor’s status is of primary interest to investors. As IMM has acknowledged, the company faces the classic conundrum of all small cap biotechs: retaining shareholder commitment while navigating a long regulatory process fraught with uncertainties and obscure to non-specialists. Prospective investors will need to exercise their own judgement on the prospects for IMM getting the all important go-ahead from regulators, the timeline for which the company itself is understandably non-committal. But with a share price at 2.7p at the time of writing – down 65pc over the year – IMM has never been cheaper. Positive news – whenever it may come – may inject new value into a share worth 7p just a couple of months ago.