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GlycoMimetics: Unraveling The Tea Leaves

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There tin ne'er beryllium surprises successful logic."― Ludwig Wittgenstein

Today, we return a look astatine mini biopharma interest called GlycoMimetics, Inc. (NASDAQ:GLYC). The banal plunged much than 50% earlier this week connected 2 pieces of news. Management announced that it had sold astir 11.8 cardinal shares of its communal banal successful an "at-the-market" offering from nan commencement of Q4 2022. This action raised astir $33 cardinal worthy of proceeds and push backmost nan company's 'cash runway' astir 1 twelvemonth to twelvemonth extremity 2024.

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The bigger news was activity besides disclosed that an independent sheet recommended that its pivotal Phase 3 study for its lead supplier campaigner uproleselan successful relapsed/refractory (R/R) acute myeloid leukemia (AML) will spell guardant arsenic initially designed.

This was very disappointing to investors. Trial information that came retired successful November (more connected that successful nan sections below) was truthful encouraging that nan FDA elected to behaviour a inferior study successful which this independent information monitoring committee would reappraisal nan information astatine 80% of planned events to find if nan study should proceed to 100% events triggered (near YE23) aliases unblind nan information early owed to compelling grounds of benefit. Unblinding nan information would person resulted successful a soon to travel NDA filing. Instead, because of this proposal that will not hap beryllium capable to hap until afloat information from this study comes retired precocious this year.

Company Overview:

GlycoMimetics, Inc. (GLYC) is simply a Rockville, Maryland based clinical-stage biopharmaceutical interest focused connected nan improvement of glycomimetic therapies that reside orphan diseases pinch precocious unmet needs. GlycoMimetics are mini molecules that mimic nan building of carbohydrates, immoderate of which are believed to play a domiciled successful inflammation, cancer, and infection. The institution has 1 objective plus (uproleselan) that is pursuing nan acute myeloid leukemia (AML) denotation and different 1 that is clinically cleared but looking for a improvement partner. GlycoMimetics was formed successful 2003 and went nationalist successful 2014, raising nett proceeds of $57.2 cardinal astatine $8.00 per share. Its banal trades conscionable nether 2 bucks a share, translating to a marketplace headdress of astir $95 million.

Proprietary Platform

Most quality proteins are modified by carbohydrates, which successful move impact really those proteins function. The institution is focusing connected a definite subset of proteins known arsenic selectins, which service arsenic adhesion molecules that hindrance to carbohydrates and are progressive successful inflammation, driving a wide scope of maladies, including cancer, cardiovascular disease, and hematologic disorders. In cancer, they are believed to play a important domiciled successful tumor metastasis and chemotherapy resistance. By processing compounds that mimic nan bioactive usability of carbohydrates pinch drug-like properties (a.k.a. glycomimetics), nan institution believes it tin inhibit nan selectins, and halt nan beforehand of disease.

Pipeline

Uproleselan. GlycoMimetics' lead campaigner is uproleselan, a circumstantial E (as successful endothelial)-selectin inhibitor that is being investigated successful operation pinch chemotherapy successful nan curen of patients pinch AML. It has been granted Fast Track nickname from nan FDA, Breakthrough Therapy Designations from regulatory authorities successful nan U.S. and China, and Orphan designations from nan FDA and EMA.

 Disrupts nan Protective Interaction Between AML

November Company Presentation

AML, for illustration astir leukemias, is treated pinch chemotherapy, which comes pinch its attendant broadside effects, including bony marrow toxicity resulting successful neutropenia - terrible infections owed to an abnormally debased number of achromatic humor cells known arsenic neutrophils - and mucositis. E-selectin binds crab cells wrong vascular niches of nan bony marrow, preventing nan cells from entering circulation, wherever they would beryllium much susceptible to chemotherapy. In preclinical animal models, uproleselan was capable to tie AML crab cells retired of nan bony marrow, resulting successful little crab load successful operation pinch chemotherapy versus chemotherapy alone. Furthermore, nan animals knowledgeable little terrible neutropenia and mucositis and little bony marrow toxicity versus chemo monotherapy.

In a Phase 1/2 proceedings that was completed successful 2018, uproleselan pinch chemotherapy demonstrated complete responses pinch aliases without complete humor count betterment (CR/Cri) successful 41% of patients successful nan refractory/relapsed cohort. Median wide endurance [OS] was 8.8 months versus ~5.3 months connected chemo unsocial (as per humanities norms). Also, 69% of evaluable patients (11/16) achieved measurable residual illness negativity. In nan recently diagnosed cohort, nan CR/CRi complaint was 72% while median OS was 12.6 months. Event free endurance was 9.2 months arsenic compared to 2.0-6.5 months connected chemo unsocial (as per humanities norms for a little consequence organization than nan 1 treated pinch uproleselan). These were very awesome results considering AML patients acquisition immoderate of nan worst 5-year OS rates comparative to different leukemias - 30.5% (2011-2018) versus an mean of ~75% amongst chronic myeloid leukemia, chronic lymphocytic leukemia, and acute lymphoblastic leukemia.

Based connected these results, uproleselan has been entered successful aggregate late-stage trials, including a double-blinded, placebo-controlled Phase 3 study to measure it successful nan curen of 388 relapsed/refractory AML patients. The patients are randomized 1:1 to person either an introductory information of uproleselan and chemo followed by 3 further cycles of uproleselan and chemo -OR- an introductory information of placebo and chemo followed by 3 further cycles of placebo and chemo. The returns to day person been perchance groundbreaking. The OS arena trigger was initially anticipated astatine ~22 months - fantabulous considering that Astellas' (OTCPK:ALPMF) Xospata and Jazz Pharmaceuticals' (JAZZ) Vyxeos were approved pinch median OS rates of 9.3 months and 9.5 months, which were triggered astatine 17.8 months and 20.5 months, respectively. However, successful an update provided successful November 2022, guidance indicated that median follow-up is now anticipated to beryllium triggered astatine 34.5 months, providing important betterment complete nan different 2 therapies.

Furthermore, GlycoMimetics' compound is being assessed arsenic a front-line therapy successful a 262-patient Phase 2/3 study successful which recently diagnosed individuals will beryllium randomized to person either an introductory information of uproleselan and chemo followed by 3 rounds of uproleselan and chemo -OR- an introductory information of chemo followed by 3 information of chemo. The Phase 2 information was afloat enrolled successful December 2021 pinch an interim readout expected sometime successful 2023.

UPROLESELAN

November Company Presentation

If successful, uproleselan would participate a marketplace wherever ~20,400 caller cases of AML were diagnosed successful nan U.S. successful 2021, of which ~12,000 were eligible for intensive chemotherapy. Although nan median property of test is 68 years, pinch an wide five-year comparative endurance complaint of 30.5% location is sizeable request for improved therapies. That said, nan title successful nan AML abstraction is important pinch 9 non-chemo narcotics approved, mostly successful operation pinch chemo aliases to dainty a circumstantial AML mutation. Furthermore, nan marketplace is not peculiarly robust, measured betwixt $659.6 cardinal (according to Industry Research) and $1.74 cardinal (iHealthcare Analyst) successful FY22, pinch expectations for nan opportunity to turn astatine an 8%-9% CAGR for nan equilibrium of nan decade.

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GMI-1687. The logic GlycoMimetics' banal had antecedently connected nan level was owed to nan broad nonaccomplishment of selectin antagonist rivipansel, which flopped successful a Phase 3 proceedings conducted by improvement and commercialized partner Pfizer (PFE) successful nan curen of patients pinch vaso-occlusive crisis, a debilitating and achy information that periodically afflicts patients pinch sickle compartment illness [SCD]. Shares of GLYC plummeted 69% successful nan pursuing trading convention (August 5, 2019) to $2.80, initiating a decease march to $0.51 by June 2022. Unsurprisingly, Pfizer pulled retired of nan collaboration successful February 2020.

In nan meantime, GlycoMimetics developed a perchance self-injectable type of uproleselan (GMI-1687), and undeterred by its first failure, is re-pursuing nan vaso-occlusive situation indication. Similar to its first foray, earlier advancing it done nan clinic, it is looking for a improvement partner. The FDA gave GMI-1687 a "Safe to Proceed" clearance for IND successful June 2022.

China Collaboration

GlycoMimetics does person 1 improvement partner successful nan shape of Hong Kong biotech Apollomics. In return for an upfront information of $9 million, imaginable milestone payments of $180 million, and gradual royalties up to 15%, Apollomics has nan improvement and commercialized authorities to some uproleselan and GMI-1687 successful Mainland China, Hong Kong, Macau, and Taiwan.

Balance Sheet & Analysts Commentary:

The institution only held rate of $51.6 cardinal connected September 30, 2022, providing it a rate runway until YE23 - made imaginable aft it laid-off 20% of its workforce (mostly preclinical staff) successful April 2022. Clearly, guidance was gambling connected uproleselan's occurrence and was waiting to spot if nan FDA would unblind its Phase 3 study. With nan caller superior raise, nan institution now has backing successful spot until precocious successful 2024.

H.C. Wainwright did reiterate their Buy standing and $8 value connected GLYC, down from $13 previously, aft Wednesday's announcement. It is nan only expert patient to chime successful truthful acold connected nan institution since news was disclosed this week.

It should beryllium noted that beneficial proprietor Scott Sandell, representing nan interests of NEA Management, has unloaded astir $13 cardinal worthy of shares since December 30, 2022.

Verdict:

With patients continuing to unrecorded importantly longer than expectations successful nan Phase 3 AML trial, nan stake was that nan FDA will unblind nan study for inferior astatine nan extremity of 1Q23.

Obviously, since it wasn't, GlycoMimetics was forced into a superior raise. However, continuation does not antagonistic nan affirmative information generated truthful acold successful that cardinal Phase 3 study. The AML opportunity is not massive, but highest uproleselan income for this denotation could easy triple GlycoMimetics existent marketplace cap. More importantly, its glycomimetic attack is being validated, mounting it up for further indications. Given that GLYC seems to merit a mini speculative finance arsenic nan banal appears to beryllium oversold. I person a position successful GLYC via covered call orders which provides important downside consequence mitigation.

Illogicality is nan deficiency of communal sense."― Sukant Ratnakar

Editor's Note: This article covers 1 aliases much microcap stocks. Please beryllium alert of nan risks associated pinch these stocks.

Live Chat connected The Biotech Forum has been dominated by chat of lucrative buy-write aliases covered telephone opportunities connected selected biotech stocks complete nan past respective months. To spot what I and nan different play biotech investors are targeting arsenic trading ideas real-time, conscionable subordinate our organization at The Biotech Forum by clicking HERE.

Editor: Naga



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