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Catalyst Biosciences (CBIO) is a clinical-stage biopharmaceutical aggregation focused on developing hemostasis treatments. Back the aggregation became accessible afterwards a alliance accord with Targacept, it is accepted that Catalyst has engineered three ameliorative candidates that adapt bleeding and is advancing two candidates into mid-stage analytic trials:

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Source: Company’s October 2018 broker presentation

The best avant-garde program, a subcutaneously, SQ, administered, next-generation engineered agglomeration Agency VIIa, activated marzeptacog alfa (MarzAA), is enrolling hemophilia patients with an inhibitor in a Phase 2/3 SQ dosing trial. The Phase 2 allotment of this abstraction is an open-label SQ adeptness balloon that will appraise the adeptness of MarzAA to eliminate/minimize ad-lib bleeding episodes in individuals with hemophilia A or B with inhibitors. The balloon is enrolling up to 12 individuals with hemophilia and an inhibitor beyond 10 all-around sites. MarzAA has been accepted bead biologic appellation by FDA for accepted prophylaxis to anticipate bleeding episodes in individuals with hemophilia A or B with inhibitors. Acting abstracts is accepted to be appear at ASH appointment in two months, in December 2018.

Source: Company’s October 2018 broker presentation

As of July 31, 2018, Catalyst has enrolled bristles individuals in the trial. One subject, with a actual annualized drain rate, ABR, of 26.7, has completed the abstraction with one drain over 96 days. The accountable accomplished one drain at Day 46 during assay with 30 µg/kg MarzAA, no bleeds during assay with 60 µg/kg MarzAA for 50 days, and a ad-lib drain 16 canicule afterwards dosing abortion in a aftereffect period. Two added capacity with ABRs of 15.9 and 16.6 are in the aboriginal 50 canicule of dosing. Pharmacokinetics studies accept apparent that MarzAA’s half-life of 3.5 hours, back dosed intravenously, was added to a half-life of 9.5 hours afterwards SQ dosing.

The aing best avant-garde hemophilia program, a next-generation engineered agglomeration Agency IX, CB 2679d/ISU 304, has completed acceptance of the originally planned bristles cohorts of a Phase 1/2 SQ dosing balloon in South Korea, that evaluated the assurance and adeptness of CB 2679d/ISU 304 in individuals with astringent hemophilia B, sponsored by Catalysts’ collaborator, ISU Abxis. The cold of this abstraction was to authenticate the achievability of accretion Agency IX action canal levels from ~1% (severe hemophilia) to >12% (mild hemophilia with a bargain adventitious of ad-lib collective bleeds) with six circadian SQ injections. CB 2679d/ISU 304 has been accepted bead biologic appellation by the FDA and bead alleviative artefact appellation by the Committee for Bead Alleviative Articles in Europe.

Data from Cohorts 1 through 3 (three capacity in anniversary cohort) showed that a distinct SQ dosage of either 75 or 150 IU/kg three canicule afterwards a distinct intravenous dose, IV, of 75 IU/kg decidedly added the half-life of CB 2679d/ISU 304 to 98.7 hours, agnate to the half-life of extended-half-life IV agents.

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Source: Company’s October 2018 broker presentation

Catalyst believes that SQ dosing of the next-generation agglomeration factors may aftereffect in bit-by-bit increases in action levels until they ability a abiding ameliorative ambition ambit in the blood. Conversely, dosing by IV infusions after-effects in aerial antecedent Agency levels in the claret followed by a accelerated fall-off in action to a canal akin in a ambit that is abstinent as moderate/severe hemophilia and consistent in college bleeding risk. Abiding and/or college agency levels could potentially crop a allusive advance in outcomes and accept the added account of accessibility over aggressive IV therapeutics, decidedly back administered to children, and area venous admission is problematic.

Based on aggregation appear sales, the 2017 all-around bazaar befalling for MarzAA is $2.2 bn and for CB 2679d is $1.2 bn:

Source: Company’s October 2018 broker presentation

We don’t think, however, that it is a big bazaar befalling for Catalyst products. It is rather a alcove market, and it additionally charcoal an accessible catechism whether Catalyst will be able to:

In agreement of competition, we will be absorption on two mid-stage activity assets and will leave out the blow of the aboriginal date activity as we anticipate alone the mid-stage activity affairs for the appraisal and M&A purposes.

Both Agency VIIa and Agency IX articles accept able competition, and about all of the competitors are large-cap biopharma companies (with abysmal pockets).

In general, it is advantageous to accept large-cap competitors because (i) they can footfall advanced with accretion bids already Catalyst makes some apparent advances in analytic development and (ii) baby companies are usually added innovative, active and disturbing to survive with its agents apprenticed by account and blah incentives as compared to accustomed companies that generally attempt to incentivize and absorb the best ambitious and bathe talent.

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For Agency VIIa Competition:

For Agency IX Competition:

As we can see, the accepted antagonism is absolutely intense. However, not abounding candidates with SQ delivery. We accept that if Catalyst can appearance some affirmation of adeptness in Phase 2, it may decidedly accession its contour and the anticipation of t-on accretion bid from accustomed players such as Shire, Pfizer, SOBI and Novo Nordisk.

Next, what’s the activity valuation? Even if the aggregation is able to affected all the hurdles – clears all the trials, secures FDA/EMA nods, and gains, say, 25% bazaar share, again we accept $1 bn in aiguille sales for both assets/indications, and a best of $1 bn of risk-unadjusted NPV. With accident adjustment, which at this point is about 90-95%, we get to ~$75 mm.

Now, if we brainstorm that Catalyst announces some allusive adeptness advance in December of this year, the aforementioned appraisal all-overs 2x to $150 mm, as Ph 2 hurdles are awfully the toughest to clear.

Catalyst has austere about $13 mm in banknote in 1H 2018, mostly on R&D and admin expenses:

Source: Company’s 2Q 2018 SEC filings

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We apprehend Catalyst to bake as abundant in 2H 2018, back there is no adumbration of boundless costs – such as launch, ample balloon enrollment, etc.

As of 06/30/2018, Catalyst had about $136 mm in cash. On 12/31/2018, we apprehend the banknote to be at about $120-123 mm accustomed the actual bake amount and management’s altercation of how it affairs to use the funds.

Source: Company’s 2Q 2018 SEC filings

Now, adorable at the antithesis area (2017/2018 comparison), the aboriginal affair that attracts absorption is the abrupt access in banknote during 2018 (around $100 mm absolute difference).

It’s because Catalyst aloft accessible disinterestedness back the blah amount was at a akin of $30 in February 2018. The aggregation offered 3,382,352 shares of its accepted blah at a amount of $34 per allotment and the gross gain from this alms were about $115 mm.

Although the accessory accepted blah alms appropriate about 30% concoction (Catalyst had about nine actor outstanding shares above-mentioned to offering), the bazaar did not acknowledge negatively.

Usually, a dilutive accessory alms after-effects in a bead of blah price, unless the alms is a attenuate arresting of some absolute account in analytic development and the accessible use of banknote for addition later-stage balloon that decidedly increases the company’s all-embracing valuation.

In case of Catalyst, afterwards the $34 per allotment accessible alms in February, annihilation cogent happened, and the blah amount gradually alone to about $25 until the account in June back the aggregation appear ambiguity about its Phase 1/2 balloon Agency IX applicant CB 2679d/ISU304 for hemophilia B treatment. The attendance of acrid antibodies in two patients may accept signaled not alone adeptness apropos in Ph 1/2 trial, but additionally the achievability of accident of those antibodies in Ph 2/3 MarzAA trial:

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Subsequent claret samples showed the attendance of a brief acrid antibiotic in one accommodating and a acrid antibiotic in the second. Importantly from a assurance perspective, the antibodies do not bind to wildtype FIX acceptance both patients to auspiciously resume assay with their assigned intravenous FIX prophylaxis therapies; the patients accept not accomplished any bleeds or added assurance issues and are actuality carefully monitored. Above-mentioned to Accomplice 6, no CB 2679d acrid antibodies had been detected in any of the patients advised with CB 2679d/ISU304, including both patients in Accomplice 6 who had additionally alternate in Accomplice 5. Catalyst is administering an assay to appraise the account and appulse of the antibiotic observations above-mentioned to dosing any added capacity in Accomplice 6.

As a aftereffect of this announcement, the blah amount alone to $10-12 levels and never recovered back then. Investors became actual apprehensive and cautious.

We charge agenda actuality that the amount bead was a bit of overreaction. Nevertheless, one way or another, we will accept added accuracy in December 2018 already we see the Ph 2/3 MarzAA acting readout at ASH conference. As Catalyst’s CEO said during contempo broker presentation:

Q4 is activity to be a big division for us with Ph II abstracts appear at ASH

Source: Company’s October 2018 broker presentation

Bulls may altercate actuality that FVIIa is 9-fold added almighty than NovoSeven and SQ commitment represents the approaching of FVIIa treatment:

Source: Company’s October 2018 broker presentation

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Or that the aggregation has a actual accomplished aggregation (we don’t necessarily accede with that because it is a tiny 30 agent company):

Source: Company’s October 2018 broker presentation

Or that Catalyst is one of the micro-cap stocks that are usually disregarded by big armamentarium managers (although we anticipate that micro-caps are like start-ups and actual chancy in general) due to assorted affidavit including clamminess concerns, advance admeasurement limitations, etc.

But the blah accuracy is that the aggregation has $136 mm in banknote and 11,942,729 shares outstanding, and burns about $13 mm banknote per 6 months. Price-to-Book amount is 1, which gives us about $10 per allotment of built-in banknote amount in 12/31/2018.

Even if we may or may not accept in the Catalyst technology, we do accept in cash. Even if the advertisement at ASH will be a complete failure, we don’t anticipate the blah amount will bead beneath $8.5. There is absolutely a accident that Ph 2 balloon will be a abortion and the aggregation still announces the admission of the big acknowledging balloon which can aftereffect in approaching banknote burn. But this is absurd in our opinion.

On the added hand, if we see some signs of acting adeptness in Ph 2/3 MarzAA trial, the blah can calmly bifold to $20-25 levels.

To blanket up, we anticipate that the advance into Catalyst blah represents an adorable risk/reward opportunity, accustomed all the risks and upsides we described.

Disclosure: I am/we are continued CBIO, ALNY.

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I wrote this commodity myself, and it expresses my own opinions. I am not accepting advantage for it (other than from Seeking Alpha). I accept no business accord with any aggregation whose blah is mentioned in this article.

Editor’s Note: This commodity covers one or added stocks trading at beneath than $1 per allotment and/or with beneath than a $100 actor bazaar cap. Please be acquainted of the risks associated with these stocks.

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