8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 4, 2020

 

 

SPERO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38266   46-4590683

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

675 Massachusetts Avenue, 14th Floor

Cambridge, Massachusetts

  02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (857) 242-1600

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value per share   SPRO   The Nasdaq Global Select Market

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 4, 2020, Spero Therapeutics, Inc. (the “Company”) updated its investor presentation (the “Investor Presentation”), which the Company expects to use in connection with general corporate presentations and will be made available on the Company’s website or distributed by the Company in hardcopy or electronic form.

A copy of the Investor Presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”). The Investor Presentation is current as of June 4, 2020, and the Company disclaims any obligation to update the Investor Presentation after such date.

In accordance with General Instruction B.2 on Form 8-K, except as set forth under Item 8.01 below, the information set forth in this Item 7.01 and the Investor Presentation is “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended.

 

Item 8.01.

Other Events.

Certain portions of the Investor Presentation are attached as Exhibit 99.2 to this Current Report and are filed with this Current Report.

Forward-looking Statements

This report, including the exhibits hereto, contains forward-looking statements. These statements include, but are not limited to, statements about the Company’s expectation that positive results from a single pivotal Phase 3 clinical trial of tebipenem HBr and ancillary supportive studies to be conducted in parallel with the Phase 3 trial will support the approval of tebipenem HBr; the design, initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and its research and development programs, including the timing of the Company’s IND submission with the FDA regarding SPR720, the commencement of the Company’s planned Phase 2a clinical trial of SPR720 and the commencement of the Company’s planned Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment; management’s assessment of the results of such preclinical studies and clinical trials; the timing of clinical data, including final data from the Phase 3 clinical trial of tebipenem HBr, final data from the Phase 1 clinical trial of SPR720 and final data from the Phase 1 clinical trial of SPR206; and the Company’s cash forecast and anticipated expenses, anticipated payments under the Company’s agreement with Everest Medicines, potential payments under the Company’s agreement with BARDA, the sufficiency of its cash resources and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the FDA will accept a single pivotal study for approval of tebipenem HBr; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether the Company’s product candidates will advance through the preclinical development and clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether the Company will satisfy all of the pre-conditions to receipt of the development milestone payment under its agreement with Everest Medicines; whether BARDA elects to exercise its second option under the Company’s agreement with BARDA; whether the Company’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether the Company’s clinical and preclinical development programs are delayed or disrupted due to the coronavirus; and other factors discussed in the “Risk Factors” set forth in filings that the Company periodically makes with the U.S. Securities and Exchange Commission. The forward-looking statements included in this report, including the exhibits hereto, represent the Company’s views as of the date of this report. The Company anticipates that subsequent events


and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this report.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit 99.1    Investor Presentation of Spero Therapeutics, Inc. dated June 4, 2020.
Exhibit 99.2    Excerpts from Investor Presentation of Spero Therapeutics, Inc. dated June 4, 2020.


SIGNATURE

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.

 

    SPERO THERAPEUTICS, INC.
Date: June 4, 2020     By:  

/s/ Stephen DiPalma

      Stephen DiPalma
      Interim Chief Financial Officer and Treasurer
EX-99.1

Slide 1

Corporate Presentation June 4, 2020 Jefferies Healthcare Conference Exhibit 99.1


Slide 2

Forward-looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, the initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and its research and development programs, including management’s assessment of such results; regulatory activities, including the Company’s expectation that positive results from a single pivotal Phase 3 clinical trial of tebipenem HBr and ancillary supportive studies to be conducted in parallel with the Phase 3 trial will support the approval of tebipenem HBr; the timing of the availability of data from the Company’s clinical trials; the timing of the Company’s filings with regulatory agencies; product candidate benefits; competitive position; business strategies; objectives of management; potential growth opportunities; potential market size; reimbursement matters; possible or assumed future results of operations; projected costs; the intention, completion and timing related to the Company’s rights offering and the intended use of proceeds from the rights offering; and the Company’s cash forecast and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards.  In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions.  All statements other than statements of historical facts contained in this presentation are forward-looking statements.  The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements.  Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials and whether preliminary data from the Company’s clinical trials will be predictive of final results from such trials; whether the Company’s product candidates will advance through the preclinical development and clinical trial process on a timely basis, or at all, taking into account such factors as the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design, clinical data requirements and clinical outcomes; whether the results of such clinical trials will warrant submission for approval from the U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agencies; decisions made by the FDA and equivalent foreign regulatory agencies with respect to the development and commercialization of the Company’s product candidates; the commercial potential of the Company’s product candidates; the Company’s ability to obtain adequate third-party reimbursement for its product candidates; the Company’s ability to implement its strategic plans; the Company’s ability to obtain, maintain and enforce intellectual property and other proprietary rights for its product candidates; the risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the company’s rights offering; whether the Company’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the “Risk Factors” section of the Company’s periodic reports and the prospectus relating to the Company’s rights offering filed with the U.S. Securities and Exchange Commission (SEC), and risks described in other filings the Company may make with the SEC in the future.  The forward-looking statements included in this presentation represent the Company’s views as of the date of this presentation. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this presentation.


Slide 3

Spero Company Overview Spero Therapeutics, Inc. is a multi-asset, clinical-stage company focused on developing and commercializing novel treatments for multidrug-resistant bacterial infections and rare diseases 1) as of 6/2/2020 2) as of 3/31/20 NASDAQ GS SPRO Market Capitalization $254M1 Cash & equivalents $88.8M2 HQ Cambridge MA Founded 2013


Slide 4

Tebipenem HBr (previously SPR994): First oral carbapenem Single Phase 3 trial required for approval in cUTI ongoing; Interim PK evaluation supports continuing trial at selected dose; Enrollment complete with topline data expected 3Q20 Phase 2 supports activity in cUTI; marketed since 2009 in Japan Pipeline of assets supported by positive Phase 1 data SPR720: First potential oral therapy for NTM infections; granted orphan designation; Phase 2 planned for 2H20 SPR206: Novel therapy for MDR Gram-negative infections; Phase 1 BAL study planned for 2H20 Multi-billion dollar opportunity for cUTI and NTM Largest unmet needs in infectious disease No approved branded or generic oral competition Marketed outside the hospital Fully funded through potential NDA filing for tebipenem HBr BARDA/DTRA award of up to $57M supports tebipenem HBr activities; additional non-dilutive funding supports pipeline Well capitalized through major inflection points Spero: Robust Rare and Infectious Disease Portfolio led by Oral Tebipenem HBr cUTI = complicated urinary tract infections; ancillary supportive studies also required for Tebipenem HBr in addition to single Phase 3 trial; NTM = non-tuberculous mycobacterial ; PK = Pharmacokinetic; MDR = multidrug resistant infections; Tebipenem HBr = tebipenem pivoxil hydrobromide (formerly SPR994)


Slide 5

Cristina Larkin I Chief Operating Officer Prior Vice President, Infection, Forest Laboratories Led the commercial hospital antibiotic franchise team at Actavis/Forest; launched Teflaro, Dalvance, Avycaz Over 22 years of experience in commercial strategy Leadership Team Ankit Mahadevia, MD I Chief Executive Officer Prior Venture Partner at Atlas Venture; Arcion Therapeutics, Genentech, McKinsey Formed eight companies in the life sciences sector; three as Acting CEO Background in healthcare policy David Melnick, MD I Chief Medical Officer Prior Vice President Clinical Development for anti-infectives; Allergan, AstraZeneca 18 years in anti-infective drug development including 16 Phase 3 trials Seven successful anti-infective drug approvals Timothy Keutzer I Chief Development Officer Prior VP Program and Portfolio Management, Cubist Extensive antibiotic development experience from pre-clinical to approval Over 20 years in the pharmaceutical industry Tom Parr, PhD I Chief Scientific Officer Prior CSO at Fedora Pharma and Targanta; Microcide, Head of Antibacterials, Eli Lilly Worked on a broad range of antibiotic classes and marketed antibiotics (oritavancin, vancomycin, ceftazidime, daptomycin) Over 26 years in drug discovery Stephen J. DiPalma I Chief Financial Officer (Interim) Managing Director of Danforth Advisors, LLC Worked as interim Chief Financial Officer to several public and emerging companies Previous Chief Financial Officer at Forum Pharmaceuticals


Slide 6

Multiple Catalysts Across the Pipeline Program Indication Preclinical Phase 1 Phase 2 Phase 3 Status Partnerships/Alliances Partnerships/Alliances Oral Carbapenem for Gram Negative Multidrug Resistant (MDR) Infections Tebipenem HBr Complicated UTI (cUTI)   Phase 3 (ADAPT – PO) enrollment complete; topline data in 3Q20   Oral DNA Replication Inhibitor for Non-tuberculous Mycobacterial (NTM) Disease SPR720 NTM   Positive Phase 1 data; Phase 2 study planned for 2H20   Direct Acting IV Potentiator for Gram Negative MDR Infections SPR206 MDR Infections   Positive preliminary Phase 1 data; Phase 1 BAL study planned for 2H20     Tebipenem HBr Enrollment Complete and Phase 3 Data Expected in 3Q20 As of May 8, 2020


Slide 7

Spero Assets Share Common Attributes With Other Successful ID Drugs Non-DRG reimbursement High unmet need with strong economic benefit $1 B+ Sales* *Estimated Peak Year Worldwide Sales


Slide 8

First Oral Carbapenem Tebipenem HBr


Slide 9

Tebipenem HBr has the Potential to be a Highly Differentiated Therapy No branded or generic oral substitutes Existing, large, and growing unmet need Primary reimbursement outside of the hospital Current practice and financial incentives support usage Prescriber base beyond infectious disease


Slide 10

Tebipenem HBr Intended to Treat a Large and Existing UTI Population Katrina, college student at the University of Kansas, experienced “a U.T.I. that did not respond to three different rounds of antibiotics.” “It got so bad that I was out of school for months and had to get a medical withdrawal,” she said. Hospital Avoidance Stay Home Timothy, a medical student, was hospitalized with E. coli that was highly resistant to a wide variety of antibiotics.  His discharge was delayed because the resistant nature of the bacteria would require insurance approval of home IV antibiotics.” Get Home Sooner From Hospital Go Home Tebipenem HBr Phase 3 Data Expected in 3Q20 Sources: NYT Aug 20, 2019; IDSA Faces of Antimicrobial Resistance


Slide 11

Lack of Oral Options for cUTI is Widespread, Costly, and Addressable 2000-2004 Hospital Community $10,741 $7,083 76% Increase in hospitalizations +2 Days Longer Stays in Hospital Resistance + No Viable Oral cUTI Option = 2.3M Avoidable Hospitalizations Major Unnecessary Cost   Growing Fluoroquinolone Resistance 2013-2014 2000-2004 2013-2014 Tebipenem HBr could help shift care back to outpatient setting: Helping patients to Go Home or Stay Home QuintilesIMS NDTI and MIDAS Database; Quintiles/IMS Market Assessment 2017, Simmering, Jacob E. et al. “The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998–2011.” Open Forum Infectious Diseases 4.1 (2017): ofw281. PMC. Web. 15 Mar. 2018.; (Simmering et al. 2011).Avoidable hospitalization estimates derived primarily from QuintilesIMS market assessment (August 2017); *Resistance estimates directly from market assessment . cUTI= Complicated urinary tract infection


Slide 1

2 Pivotal Phase 3 Trial Evaluates Oral Tebipenem HBr Efficacy Equivalence to IV Ertapenem Randomization All Oral Tebipenem HBr ~685 patients All IV Ertapenem ~685 patients Primary Endpoint Head-to-Head Comparison: Oral vs. IV† Oral Only Tebipenem HBr (600mg TID) IV Only Ertapenem (1g q24h) Duration of therapy 7-10 days Adult patients ≥18 years Innovative Trial Design Compares an Oral-Only Regimen Directly Against and IV Regimen for cUTI and Acute Pyelonephritis †Showing active treatment arm only; study is placebo-controlled double-blind, double-dummy ‡ Combined Clinical Cure and Microbiological Eradication (non-inferiority margin of 10%). Additional evaluation at LFU (23-27 days after first dose of study drug) PK lead-in data from 33 patients support continuing without dose modification (Oct 2019)* Screening Overall Response‡ rate at TOC in micro-ITT population (17-21 days after first dose of study drug) vs. Abbreviations: cUTI, complicated urinary tract infection; ITT, intent-to-treat; IV, intravenous; LFU, long-term follow-up; q24h, every 24 hours; TID, three times daily; TOC, test-of-cure. Masked individual and composite PK data reviewed by an independent review committee after enrolling the first 70 patients to confirm dose; trial remains blinded


Slide 13

Safety, Efficacy and Pharmacokinetic Data Support Ongoing Tebipenem HBr Phase 3 Trial Approximately 60% oral bioavailability High drug levels at infection site Interim Phase 3 data on plasma PK levels in patients confirms treatment dose Phase 2 cUTI studies demonstrate comparability to the efficacy of approved IV agents Marketed in Japan for over 10 years; 3,540 patient safety database


Slide 14

Tebipenem Pivoxil Phase 2 Data are Supportive of Activity in cUTI Tebipenem pivoxil hydrobromide = Spero’s API, orally available prodrug salt; listed doses refer to dose of active tebipenem. Tebipenem pivoxil = Meiji’s API, orally available prodrug; Phase 2 conducted by Meiji Note: No head-to-head studies have been conducted and as such the data cannot be directly compared Sources:: 1) Tebipenem-PI Studies - L-084 04 CSR; ME-1211-1 CSR; cUTI subset of Phase 2 data; 2) Wagenlehner et al, Clin Inf Dis 63:754, 2016; 3) Kaye et al, JAMA 319:788, 2018 – Removable = removable cystitis, no N provided Dose ranging studies with tebipenem pivoxil completed in 72 patients from 300mg to 900mg daily dose in cUTI caused by lower UTI Infections Response rates at TOC in the tebipenem pivoxil studies align well with response rates at TOC for intravenously administered approved drugs in this patient subset2,3 Microbiological Eradication at TOC 


Slide 15

Urine Concentration of Tebipenem HBr after a Single Dose Free Plasma Concentrations of Tebipenem HBr 50% of TID dosing interval 600mg dose provides >50% fT>MIC for E. coli and K. pneumoniae, the most prevalent cUTI pathogens High urine concentration affords additional margin of exposure in cUTI High Urine and Plasma Exposures in Clinical Trials Support Tebipenem HBr Phase 3 Dose Data from Phase 1 SAD/MAD trial


Slide 16

Tebipenem HBr Stay Home Opportunity 1.2M (13%) patients have Resistant/ Recurrent infections or Fail oral therapies and have to receive IV antibiotics* ~$10,700 Hospitalization cost OR ~$5,000 OPAT cost + 25% complication rate *99% of patients are eligible for oral therapy 9.2M UTI patients will receive an RX for oral antibiotics in the community 8M (86%) patients improve on orals Tebipenem HBr restores the ability to treat RRF UTI patients with oral therapy Effective oral therapy is preferred & achievable for most patients Source: Allison GM, Muldoon EG, Kent DM, et al. Prediction model for 30-day hospital readmissions among patients discharged receiving outpatient parenteral antibiotic therapy. Clin Infect Dis. 2014;58(6):812-819. doi: 10.1093/cid/cit920 https://www.the-hospitalist.org/hospitalist/article/128764/transitions-care/ready-post-acute-care; FQ = Fluoroquinolone; CPH = Cephalosporin ; OPAT - Outpatient Parenteral Antimicrobial Therapy


Slide 17

Tebipenem HBr Go Home Opportunity 1M (35%) are resistant to oral therapies and must remain on IV antibiotics +2 Days longer in Hospital & ~$2K/day Loss to Hospital per patient & ~$9,000 Post Acute Care costs per patient 3.3M UTI patients either require hospitalization or acquire UTI during hospitalization 1.8M (65%) will transition to oral therapy and go home (85% of patients will be ready to transition by day 3-4) Tebipenem HBr should enable transition to oral for more patients Effective oral options are critical for transitions of care Source: Allison GM, Muldoon EG, Kent DM, et al. Prediction model for 30-day hospital readmissions among patients discharged receiving outpatient parenteral antibiotic therapy. Clin Infect Dis. 2014;58(6):812-819. doi: 10.1093/cid/cit920 https://www.the-hospitalist.org/hospitalist/article/128764/transitions-care/ready-post-acute-care FQ = Fluoroquinolone; CPH = Cephalosporin ; OPAT - Outpatient Parenteral Antimicrobial Therapy


Slide 18

Total Patients Oral Resistant* Eligible for oral Target Population Community UTI Hospital Avoidance 9.2M 13% 99% 1.2M Hospital UTI Shorten LOS 3.3M 35% 85% 1M Infection Prevalence (In millions) Addressable DOT (In millions) Price Value (in billions) Branded Agents (approved or in late development) UTI 12.5 16 $350 $5.4 2 Tebipenem HBr is a Multi-Billion Dollar Market Opportunity US Market Opportunity Overview x = = X X = Source: Estimates derived primarily from QuintilesIMS market assessment (August 2017); *Resistance estimates directly from market assessment FQ: Fluoroquinolone *Estimated resistance in 2021. Assumes pricing estimate per day at of $350


Slide 19

Zyvox MRSA Gram-positive Market Tebipenem HBr FQ-R Gram-negative Market Mkt size (pts) 1.8 M 2.2 M Resistance to oral options at launch 29% 36% Resistance to oral options at peak 64% 66%* Reimbursement landscape Restricted Restricted Pricing model Premium Premium Zyvox Launch Curve-Time to Peak 5 Years to Peak Retail reaches peak share by Q20 Quarters Since Launch Zyvox $1.4 B Peak Year “Go-Home/Stay Home” Analogue for Tebipenem HBr Launch *Estimated for tebipenem HBr column based on 5.5% growth rate Market Size for Zyvox is based on 14 M community cSSSI visits @ 5% resistance & 3.3 M hospital visits @ 29%. MS extended units and sales for linezolid; Resistance trends, Moran, New England Journal Med 355:7;2006; Monique R. Bidell et al. Antimicrob. Agents Chemother. 2016;60:3170-3173; OFID • Simmering et al; 2017 Winter.


Slide 20

Rare Disease Pipeline SPR720


Slide 21

Severe cough “It [coughing] could go on for a good 90 minutes, and I'm just down on the floor, on my knees, grabbing my ribs, hacking.” Fatigue “I've been in the grocery store with the shopping cart, but I didn't have the energy to wait in line to check out.” Dyspnea Limits the types of activities that people are able to do, including walking, shopping, or traveling. Non-tuberculous mycobacterial disease (NTM) causes chronic and serious lung disease with debilitating symptoms that leads to a decline in lung function. It can have a significant physical and emotional impact on patients. SPR720 has orphan drug designation and could be the first and only oral treatment for NTM NTM: An Absence of Effective and Well-tolerated Drugs Leaves Patients Without Options Source: The voice of the Patient; Non-Tuberculous Mycobacterial (NTM) Lung Infection Public Meeting: October 15, 2015 Report Date: April 2016 


Slide 22

Current Therapies for NTM Have Limitations Better options are needed for the more than 75% of non-refractory patients without approved therapies Arikayce® (Approved Inhaled Therapy) Generic Standard of Care SPR720 (Oral Product Candidate) Tolerability Poor Poor Well tolerated up to 1000 QD dose in Phase 1 Proven Activity in Naïve and Newly Treated Patients No Limited Will assess in Phase 2 trial; initiation planned for 2H20 Oral Therapy No Yes Yes QD = Daily  


Slide 23

SPR720: First Novel Oral Candidate Designed to Treat NTM Infections Broad spectrum, well-tolerated oral candidate: applicable to both non-refractory and refractory patients More than 75% of NTM patients are non-refractory; lack any approved options to treat NTM Planned once daily dose supported by clinical and non-clinical studies across multiple NTM pathogens Selected 500 - 1000mg once daily dose range for Phase 2 supported by concordant in vivo and in vitro PK/PD models BAL study in non-human primates supports lung exposure; macrophage data shows intracellular and extracellular activity Favorable safety/tolerability profile Data at 500 - 1000mg once daily in Phase 1 SAD/MAD studies supportive of advancement to Phase 2 clinical studies


Slide 24

Refractory Inhaled Arikayce® approved for NTM Anatomical disease (fixed lung injury) Treatment benefits limited by: Declining lung function Additional co-morbidities SPR720 Patient Focus Inflammatory disease (tissue burden drives inflammatory response) Treatment Naïve Bronchial hygiene/ clearance, exercise, education Colonization Treatment Inexperienced No specific NTM treatments approved; SOC of poorly tolerated antibiotic regimens Inflammatory disease (tissue burden drives inflammatory response) Delay treatment due to: Intolerability Inconvenience Ineffectiveness SPR720 target population


Slide 25

SPR720 Support for Advancement to Phase 2 ✓ ✓ ✓ ✓ Recent FDA meeting supportive of stepwise development plan Acknowledged Phase 2a trial including the clinical trial endpoints and duration of therapy as an appropriate next development step Longer-term development of SPR720 as part of a combination regimen will incorporate patient reported outcomes In vitro and in vivo studies PD modeling Phase 2a monotherapy trial in NTM patients Demonstrate activity, tissue penetration Identified predicted therapeutic exposure range Safety pharmacology, preclinical toxicology Safe and well tolerated at selected dose range SAD/MAD Phase 1 500mg - 1000mg QD is safe and well tolerated Phase 2b/3 combination trial in NTM patients Efficacy, safety and tolerability over longer duration PK, safety, tolerability and microbiology over 28 days


Slide 26

Proposed Phase 2a: Early and Robust Clinical Proof of Concept Next Steps for the Development Plan Phase 2a Trial in NTM If trial results are positive, SPR720 would be the only agent shown to drive early microbiological response as a stand-alone agent versus placebo Treatment Population Treatment Arms Objectives Treatment inexperienced patients Placebo SPR720 – 500mg SPR720 – 1000mg Standard of Care Over 28 Days Evaluate: Safety Tolerability Plasma PK Microbiological response IND submission and Phase 2a initiation: 2H20


Slide 27

Multiple Ascending Dose Cohorts (N = 40) Single Ascending Dose Cohorts (N = 56) Phase 1 SAD/MAD Data Supports Advancing to Phase 2 Trial Data indicates therapeutic exposure can be attained with a well-tolerated dose (500 – 1000mg once daily) Well Tolerated No SAEs reported; Mild GI symptoms at >1500mg PK analysis shows dose dependent increase in plasma exposure No clinically significant differences in safety or PK between healthy elderly and healthy non-elderly subjects 500mg and 1000mg doses well tolerated over 7- and 14-day dose ranges No SAEs reported; Most common AE among all cohorts was mild diarrhea not requiring discontinuation of therapy No clinically significant lab findings: ALT levels >1.5x ULN noted in 3 subjects; maximum values <3x ULN and rapidly reversible. No Hy’s law cases One discontinuation in 1500mg dose cohort: pancreatic enzyme elevation that was asymptomatic, monitorable and reversible Notes: Patients randomized 3:1 to SPR720 or Placebo


Slide 28

SPR720 500mg – 1000mg QD dose range supported by: Proposed Once Daily Phase 2 Treatment Dose is Supported by Several Models In vitro models In vivo models Hollow fiber M. avium infection model Inhibitory concentrations (MIC90) <4mg/mL for clinically relevant NTM strains. Favorable to amikacin Activity comparable to amikacin and clarithromycin in murine NTM infection models Additive effect in combination regimens Dose-related bactericidal activity comparable to clarithromycin PD driver AUC/MIC with suppression of resistance at attainable plasma exposure


Slide 29

SPR720 Demonstrated Dose Response Lung Infections in Multidrug Resistant M. abscessus Strains in Murine Models 8 6 4 2 0 Lung burden (Log10CFU) Control – day 27 Control – day 61 SPR720 25 mg/kg SPR720 50 mg/kg SPR720 100 mg/kg AMK 150 mg/kg n = 6 n = 6 n = 6 n = 6 n = 6 n = 6 Multidrug resistant M. abscessus strain infection set for 27 days, dosing in SCID mice days 27 to 61. AMK=Amikacin SQ dosed every 24h. SPR720 dosed every 48h at the doses listed above


Slide 30

Direct Acting IV Potentiator: SPR206


Slide 31

Well-tolerated at doses likely to be within a therapeutic range for MDR Gram-negative bacterial infections Mean plasma drug exposures concordant with models predictive for clinical efficacy against target Gram-negative pathogens Phase 1 SAD/MAD Preliminary Data (N = 96) Preclinical Data Supports Increased Efficacy Beyond Traditional Antibiotics SPR206 Meropenem Amikacin % isolates inhibited (n=20) MIC (μg/mL) MIC (μg/mL) MIC (μg/mL) SPR206 Phase 1 Data and Preclinical Potency Against XDR Gram-Negative Pathogens Support Advancement


Slide 32

Major Near-term Pipeline Catalysts SPR720 SPR206 3Q20: Top-line pivotal Phase 3 ADAPT- PO clinical trial results in cUTI 2H20: Initiate Phase 1 BAL study in healthy subjects 1Q21: NDA filing with the FDA for cUTI indication Oral Carbapenem Gram-negative Infections Tebipenem HBr Oral DNA Replication Inhibitor NTM Disease IV Next Generation Polymyxin Gram-negative Infections 2H20: Submit IND to FDA 2H20: Initiate Phase 2a proof-of-concept clinical trial in NTM disease 2H20: Initiate Phase 1 BAL study in healthy subjects 2021: Initiate renal impairment study


Slide 33

Financial Overview Funded into the first quarter of 2021, beyond a potential tebipenem HBr NDA filing BARDA/DTRA non-dilutive funding support for tebipenem HBr up to $56.7M; additional awards and alliances provide funding for pipeline $ in 000’s Income Statement Three Months Ended March 31, 2020 Total Revenue $1,701 R&D Expense $20,436 G&A Expense $4,086 Loss from Operations $(22,821) Net Loss Attributable to Common Stockholders $(23,258) Balance Sheet As of March 31, 2020 Cash, Cash Equivalents and Marketable Securities $88,841


Slide 34

Experienced management team Key Investment Highlights Accelerated path to market Significant near-term catalysts Pipeline products with a solid value proposition Multiple drugs in clinical development Large and existing market opportunities

EX-99.2

Slide 1

SPR720 Support for Advancement to Phase 2 ✓ ✓ ✓ ✓ Recent FDA meeting supportive of stepwise development plan Acknowledged Phase 2a trial including the clinical trial endpoints and duration of therapy as an appropriate next development step Longer-term development of SPR720 as part of a combination regimen will incorporate patient reported outcomes Exhibit 99.2 In vitro and in vivo studies PD modeling Phase 2a monotherapy trial in NTM patients Demonstrate activity, tissue penetration Identified predicted therapeutic exposure range Safety pharmacology, preclinical toxicology Safe and well tolerated at selected dose range SAD/MAD Phase 1 500mg - 1000mg QD is safe and well tolerated Phase 2b/3 combination trial in NTM patients Efficacy, safety and tolerability over longer duration PK, safety, tolerability and microbiology over 28 days


Slide 2

Proposed Phase 2a: Early and Robust Clinical Proof of Concept Next Steps for the Development Plan Phase 2a Trial in NTM If trial results are positive, SPR720 would be the only agent shown to drive early microbiological response as a stand-alone agent versus placebo Treatment Population Treatment Arms Objectives Treatment inexperienced patients Placebo SPR720 – 500mg SPR720 – 1000mg Standard of Care Over 28 Days Evaluate: Safety Tolerability Plasma PK Microbiological response IND submission and Phase 2a initiation: 2H20


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Multiple Ascending Dose Cohorts (N = 40) Single Ascending Dose Cohorts (N = 56) Phase 1 SAD/MAD Data Supports Advancing to Phase 2 Trial Data indicates therapeutic exposure can be attained with a well-tolerated dose (500 – 1000mg once daily) Well Tolerated No SAEs reported; Mild GI symptoms at >1500mg PK analysis shows dose dependent increase in plasma exposure No clinically significant differences in safety or PK between healthy elderly and healthy non-elderly subjects 500mg and 1000mg doses well tolerated over 7- and 14-day dose ranges No SAEs reported; Most common AE among all cohorts was mild diarrhea not requiring discontinuation of therapy No clinically significant lab findings: ALT levels >1.5x ULN noted in 3 subjects; maximum values <3x ULN and rapidly reversible. No Hy’s law cases One discontinuation in 1500mg dose cohort: pancreatic enzyme elevation that was asymptomatic, monitorable and reversible Notes: Patients randomized 3:1 to SPR720 or Placebo