UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On June 25, 2024, Allakos Inc. (the “Company”) released an updated corporate presentation. A copy of the presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
All of the information in this Item 7.01 and Item 9.01 of this Form 8-K, including the attached Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Allakos Inc. |
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June 25, 2024 |
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/s/ H. Baird Radford, III |
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H. Baird Radford, III |
Corporate Presentation June 2024 Developing Therapeutic Antibodies Targeting Allergic, Inflammatory and Proliferative Disease Exhibit 99.1
Disclaimer This presentation contains forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding the financial position of Allakos Inc. (“Allakos,” the “Company,” “we” or “our”); estimated lirentelimab closeout, severance and other costs; the timing of payment of restructuring expenditures; estimated ending 2024 cash, cash equivalents and investments; estimated cash runway; business strategy; plans and objectives for future operations; our expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates; our expectations with regard to the initiation, design, timing and results of our clinical studies, preclinical studies and research and development programs, including the timing and availability of data from such studies; our preclinical, clinical and regulatory development plans for our product candidates; and our anticipated milestones are forward-looking statements. Allakos has based these forward-looking statements on its estimates and assumptions and its current expectations and projections about future events. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this presentation speak only as of the date of this presentation and are subject to a number of risks, uncertainties, and assumptions, including, but not limited to: the Company’s stages of clinical drug development; the Company’s ability to timely initiate and complete clinical trials for AK006; the Company’s ability to obtain required regulatory approvals for its clinical trials; uncertainties related to the enrollment of patients in its clinical trials; the Company’s ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of clinical trials, regardless of the outcomes of preclinical testing and prior clinical trials; the Company’s ability to advance additional product candidates beyond AK006; the Company’s ability to obtain additional capital to finance its operations; general economic and market conditions; and other risks described in the “Risk Factors” section included in our periodic filings that we have made and will make with the Securities and Exchange Commission (“SEC”). In addition, Allakos operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for Allakos’ management to predict all risks, nor can Allakos assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements that Allakos may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Allakos does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Allakos’ expectations, except as required by law. Accuracy of Data: This presentation contains statistical data based on independent industry publications or other publicly available information, as well as other information based on Allakos’ internal sources. We have not independently verified the accuracy or completeness of the data contained in these industry publications and other publicly available information. Accordingly, Allakos makes no representations as to the accuracy or completeness of that data. Additional Information: The Company has filed and will file Current Reports on Form 8-K, Quarterly Reports on Form 10-Q, and Annual Reports on Form 10-K, and other documents with the SEC. You should read these documents for more complete information about the Company. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. This presentation concerns products that are under clinical investigation, and which have not yet been approved for marketing by the U.S. Food and Drug Administration. It is currently limited by federal law to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated. Allakos and the 3-circles design are federally registered trademarks owned by Allakos Inc. Any unauthorized use is expressly prohibited
Allakos Opportunity Novel Target Milestones 3Q24 – Report safety, PK, and PD results from the Phase 1 trial of subcutaneous AK006 in healthy volunteers YE24 – Report topline Phase 1 data of AK006 in patients with CSU AK006 (anti-Siglec-6 mAb) selectively inhibits multiple modes of mast cell activation Inhibits IgE-dependent and IgE-independent mast cell activation pathways, including IgE, KIT and MRGPRX2 Depletes mast cells by ADCP in the presence of activated macrophages Upcoming Data Catalysts and Expected Milestones AK006 has the potential to treat a broad range of mast cell driven diseases AK006 to be tested in Chronic Spontaneous Urticaria (CSU) and one additional proof-of-concept study Significant Need for New Agents
Mast Cells Are Key Drivers of Inflammatory Disease IL-13
Leveraging the Native Inhibitory Function of Siglecs on Mast Cells Activated State Siglec-Mediated Inhibition Mast cells can be activated by numerous receptors leading to mast cell degranulation and release of histamine, TNFα and other inflammatory mediators Activation of Siglec-6 with an agonistic antibody activates inhibitor machinery inside cell which attenuates activating signals SOURCE: O’Sullivan J et al. Seminars in Immunology. 2023 Jul; 4; 69:101799
AK006 is Engineered for Deep Mast Cell Inhibition AK006 is a Siglec-6 mAb that selectively inhibits mast cells and reduces their numbers Engineered for deep mast cell inhibition Reduces mast cells via ADCP in presence of activated macrophages AK006 inhibits multiple mast cell activation pathways including IgE, IL-33, KIT, C5a and MRGPRX2 The Phase 1 study of AK006 consists of single and multiple ascending doses administered in healthy volunteers, followed by a randomized, double-blind, placebo-controlled, CSU cohort AK006 (Anti-Siglec-6)
Program Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Milestone AK006 (Anti-Siglec-6) Healthy Volunteers & CSU Expected SC results from healthy volunteers in 3Q24; Expected CSU results at YE24 AK068 (Siglec-6/Siglec-8 Bispecific) Inflammatory Diseases Ongoing T Cell Immunomodulatory Receptors Inflammatory Diseases Ongoing AK007 (Anti-Siglec-10) Immuno-Oncology Ongoing Allakos Pipeline
Mast Cells Play a Significant Role in Many Diseases Mast Cell Activation Syndrome Indolent Systemic Mastocytosis Chronic Urticaria Atopic Dermatitis Eosinophilic Gastritis Eosinophilic Esophagitis Eosinophilic Duodenitis Ulcerative Colitis Vernal Keratoconjunctivitis GASTROINTESTINAL DISEASES OPHTHALMIC DISEASES RESPIRATORY DISEASES SKIN DISEASES MULTI-ORGAN DISEASES Atopic Keratoconjunctivitis Asthma Perennial Allergic Conjunctivitis Chronic Obstructive Pulmonary Disease Idiopathic Pulmonary Fibrosis Prurigo Nodularis Crohn’s Disease
AK006: Siglec-6 mAb that Selectively and Potently Inhibits Mast Cells
Siglec-6 is a more potent inhibitory receptor than Siglec-8 Siglec-6 regulates more cellular processes than Siglec-8: Signal Transduction Transcription Translation Cellular metabolism Degranulation AK006 has two key attributes Long residence time on the cell surface which correlates to increased inhibitory activity Antibody Dependent Cellular Phagocytosis (ADCP) AK006 Targets a Different Receptor Than AK002 with Different Underlying Biology Siglec-6 Biology and AK006
Siglec-6 and Siglec-8 Differentially Interact with Proteins that Regulate Mast Cell Activity Gray lines represent direct interaction Cytokine Signaling Protein Processing (Translation) TGFb Signaling Interferon-Related Cytoplasmic Transport Mitochondrial Translocation Ubiquitin Activity (Protein Degradation) Pyrophosphate Metabolism (Cellular Metabolism/ATP) Serine/Threonine Phosphatases (Signal Transduction) Pyruvate Metabolism (Cellular Metabolism) SOURCE: Korver, W. et al Allergy 2024.
AK006 was Designed to Drive Deep Mast Cell Inhibition AK002 AK006 Mast cell inhibition for AK002 and AK006 requires Fc-Fc𝛾 receptor interaction Binding of AK006 leads to minimal receptor internalization, resulting in greater mast cell inhibition AK006 displays a high residence time on mast cells which is associated with optimal inhibition AK006 induces antibody dependent cellular phagocytosis
AK006 Displays Greater Mast Cell Inhibition than AK002 in Preclinical Studies IgE Activation AK006 inhibits IgE-dependent and IgE–independent modes of mast cell activation better than AK002 n=3 human donors SOURCE: Korver, W. et al Allergy 2024; Benet Z, et al. AAAAI 2024 Presentation. KIT Activation Peritoneal Mast Cells MRGPRX2 Activation Lesional Monocytes **** p < 0.0001, n=8-14 mice/group *** p < 0.001, n=7-8 mice/group
AK006 Reduces Human Mast Cells via Antibody-Dependent Cellular Phagocytosis in Preclinical Studies In addition to mediating broad inhibition, AK006 can reduce mast cell numbers Ex Vivo Human Tissue Mast Cells - IFN𝞬 Activated Macrophages + IFN𝞬 Activated Macrophages Mast Cells in Tissue * p < 0.05; n=3 human donors In Vitro ADCP Assay SOURCE: Benet Z, et al. AAAAI 2023 Presentation.
AK006 Inhibits IgE-Mediated Mast Cell Activation Similar to Remibrutinib IgE-Activated Human Tissue Mast Cells AK006 inhibits IgE-mediated mast cell activation Human Mast Cell Activation Assay n=3 human donors SOURCE: Korver W, et al. EAACI 2023 Presentation.
AK006 Protects Against Systemic Anaphylaxis in Humanized Mice Humanized Model of Anaphylactic Death Systemic Anaphylaxis AK006 inhibits IgE-mediated mast cell activation in vivo Humanized Mouse Model of Anaphylaxis Anaphylactic Death SOURCE: Schanin, J et al. Communications Biology 2022 **** p < 0.0001, n=8-15 mice/group * p < 0.05, n=6-7 mice/group
AK006 Resolves Gastric Inflammation in Oral Food Challenge Model AK006 shows inhibitory and depleting effects in food challenge model Stomach Mast Cells * p < 0.01, n=6 mice/group Transcriptional Profiling of Stomach Mast Cells Corporate Model of OVA-Induced Allergic Enteritis SOURCE: Benet Z, et al. EMBRN 2022 Presentation.
AK006 in Phase 1 Clinical Study in Healthy Volunteers and Chronic Spontaneous Urticaria
AK006 Phase 1 Study Design Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts in Healthy Volunteers Randomized, double-blind, placebo-controlled Intravenous AK006 SAD: 5, 20, 80, 240, 720 mg MAD: 80, 240, 720 mg monthly Subcutaneous AK006 150 and 720 mg Planned CSU Cohort Randomized, double-blind, placebo-controlled Moderate-to-severe antihistamine refractory CSU UAS7 score ≥16 and HSS7 score ≥8 at baseline Four doses of AK006 IV given monthly SAD and MAD Cohort Safety and tolerability Pharmacokinetics Pharmacodynamics Target receptor engagement in skin biopsies SC Bioavailability CSU Cohort Therapeutic activity assessed by changes in UAS7 at week 14 Safety and tolerability Trial Cohorts Endpoints
Phase 1 IV SAD & MAD Baseline Demographics and Characteristics Characteristics Single Ascending Dose (IV) Multiple Ascending Dose (IV) Baseline Characteristics AK006 5mg AK006 20mg AK006 80mg AK006 240mg AK006 720mg Placebo AK006 80mg AK006 240mg AK006 720mg Placebo Subjects, n 12 6 6 6 6 12 6 6 6 6 Age (years), Median 26.0 23.5 26.5 26.5 29.5 26.5 24.0 33.0 27.0 27.0 Female (%) 16.7% 16.7% 16.7% 33.3% 50.0% 16.7% 16.7% 66.7% 16.7% 16.7% Weight (kg), Median 82.4 71.4 80.6 81.5 70.0 75.4 83.2 72.6 78.2 79.9 BMI (kg/m2), Median 27.3 25.3 27.1 27.7 26.2 25.0 26.6 26.3 24.6 26.4
AK006 was Well-Tolerated with a Favorable Safety Profile Single and multiple IV doses of AK006 up to 720 mg were well-tolerated with a favorable safety profile There were no serious adverse events (SAEs) There were no treatment emergent adverse events leading to discontinuation of AK006 There were no dose limiting toxicities The most common adverse events occurring in subjects on AK006 were headache and dysmenorrhea, all of which were mild-to-moderate in severity Safety follow up is ongoing
AK006 Shows Linear Exposure with a Half-life of 21 Days at 720mg Days Days Mean (±SD) Serum Concentration (µg/mL) AK006 720 mg AK006 240 mg AK006 80 mg AK006 achieved serum concentrations consistent with levels demonstrating inhibitory activity in preclinical experiments AK006 720 mg AK006 240 mg AK006 80 mg AK006 20 mg AK006 5 mg Single-dose concentration-time profile Multi-dose concentration-time profile
High Siglec-6 Occupancy is Observed at Low Doses Siglec-6 receptor occupancy on mast cell cells from skin biopsies was quantified in the Phase 1 study of AK006 Doses of AK006 ≥20mg showed mean Siglec-6 receptor occupancy >90% on skin mast cells at Day 29 The high occupancy levels on skin mast cells confirm that systemically administered AK006 has good distribution into the skin Route Dose Cohort (mg) n Baseline Day 8 Day 29 IV PBO 9 0 9 24 SAD IV 5 7 0 98 45 20 6 0 97 92 80 6 0 87 96 240 6 0 97 94 720 6 0 94 101 Siglec-6 Receptor Occupancy (mean, %) Each patient (n) received a biopsy at (1) baseline and (2) either Day 8 or Day 29.
AK006 for Chronic Spontaneous Urticaria
AK006 May Inhibit Disease Driving Pathways in Urticaria Activated mast cells drive the pathogenesis of urticaria via release of inflammatory mediators resulting in pruritis, vasodilation, and increased vascular permeability Blocking both IgE activation and IgE-independent mast cell activation could result in improved patient outcomes in CSU IgE activation of mast cells, from autoantibodies or allergens, has been identified as driving pathogenesis in a proportion of patients with chronic urticaria IgE-independent mast cell activation, via MRGPRX2 and other mast cell receptors, is also believed to contribute to symptoms SOURCE: Voss, M.; Int. J. Mol. Sci. 2021, 22, 4589. doi.org/10.3390/ijms22094589; Siiskonen H. Front Cell Neurosci. 2019;13:422. Published 2019 Sep 18. doi:10.3389/fncel.2019.00422 Urticaria
Chronic Spontaneous Urticaria Opportunity CSU affects up to 3 million adults in the U.S., with 2 million managed by a specialist (allergist or dermatologist)1,2 Approximately 800k adult CSU patients are eligible for a biologic in the U.S. 1. Maurer M, et al. Allergy. 2011 Mar;66(3):317-30. 2. Allakos allergist and dermatologist market research survey (N=208), Nov 2021. 3. Decision Resources Chronic Urticaria Report, Nov 2020. 4. Novartis 2021 annual report and earnings call 800k (40%) moderate-to-severe and inadequately controlled with H1-AH(2) 2 million adult CSU pts managed by a specialist(2) Treated with Xolair(3) (~10% of biologic-eligible patients) 80k An estimated 800k adults with CSU are biologic-eligible, yet only approximately 10% of eligible patients are currently on a biologic2,3 Currently only Xolair is approved for the treatment of antihistamine CSU. Xolair® (omalizumab) global CSU sales were estimated to be $1.6 billion in 20214
Chronic Spontaneous Urticaria Landscape Drug Name MOA UAS7 Response Opportunity Xolair® (omalizumab) Anti-IgE mAb Dose Group1 150 mg 300 mg Placebo Placebo >50% of patients continue to have symptoms Black box for anaphylaxis1 UAS7 -14.4 (-48%) -20.8 (-66%) -8.0 (-26%) -8.0 (-26%) UAS7=0 15% 36% 9% 9% Dupixent® (dupilumab) Anti IL-4/IL-13R mAb Dose Group2 300 mg 300 mg Placebo Placebo Q2W dosing No improvement in Xolair failures3 UAS7 -20.5 (-65%) -20.5 (-65%) -12.0 (-37%) -12.0 (-37%) Barzolvolimab Anti KIT mAb Dose Group4 75 mg Q4W 150 mg Q4W 300 mg Q8W Placebo c-Kit is expressed on hematopoietic stem cells, melanocytes, CNS and germ cells5 UAS7 -17 (-56%) -23 (-75%) -24 (-76%) -10 (-35%) UAS7=0 23% 51% 38% 6% Dose Group6 25 mg BID Placebo BTK is expressed on hematopoietic cells including B cells, myeloid cells, and platelets7 Remibrutinib BTK Inhibitor UAS7 -20 & -20 (-65% & -65%) -12 to -14 (-40% to -46%) Warnings and Precautions: hemorrhage, infections, cardiac arrhythmias & failure, hypertension, cytopenia, malignancies8 UAS7=0 28% to 31% 7% to 11% SOURCE: 1.) Xolair Label; UAS7 scores are calculated change from baseline and percentage change; 2.) Sanofi PR 7/29/21 3.) Sanofi PR 2/18/22 4.) Celldex Presentation 11/6/23 5.) N.F. Russkamp et al. Experimental Hematology 2021;95:31−45 6.) Saini S, et al. ACAAI 2023 Presentation 7.) Garg N et. al. J Clin Med 2022; 11(20):6039
Financial Overview & Key Milestones
Data Catalysts and Expected Milestones Q2 2024: Report SAD and MAD safety, pharmacokinetics (PK), and pharmacodynamic (PD) results from the Phase 1 IV AK006 trial in healthy volunteers, including data to confirm Siglec-6 receptor occupancy in skin biopsy samples. Q2 2024: Initiate the randomized, double-blind, placebo-controlled Phase 1 trial of IV AK006 in patients with chronic spontaneous urticaria (CSU). Q3 2024: Report subcutaneous (SC) AK006 safety, PK, and PD results from the Phase 1 trial in healthy volunteers, including data to confirm Siglec-6 receptor occupancy in skin biopsy samples. YE 2024: Report topline data from the Phase 1 trial of IV AK006 in patients with CSU.
Cash, Cash Equivalents and Investments in Marketable Securities as of December 31, 2023 $170.8 M – Estimated 2024 cash used in restructuring (lirentelimab closeout, severance and other costs) $30 M – Estimated 2024 cash used in ongoing business operations $55 to $60 M Estimated, Cash, Cash Equivalents and Investments in Marketable Securities at year end 2024 $81 to $86 M Common Shares Outstanding as of December 31, 2023 87.8 M Allakos expects that the restructuring activities will extend the cash runway into mid-2026 AK006 composition of matter to expire in 2042 without extensions Planning subcutaneous AK006 for Phase 2 studies Balance Sheet and IP Protection