8-K
PTC THERAPEUTICS, INC. (PTCT)
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): May 17, 2023
PTC THERAPEUTICS, INC.
(Exact Name of Company as Specified in Charter)
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| Delaware | 001-35969 | 04-3416587 | ||
| (State or Other Jurisdiction | | (Commission | | (IRS Employer |
| of Incorporation) | | File Number) | | Identification No.) |
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|---|---|---|
| 100 Corporate Court | | |
| South Plainfield , NJ | | 07080 |
| (Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (908) 222-7000
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
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:
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| Title of each class | **** | Trading Symbol(s) | **** | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share | | PTCT | | 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.
PTC Therapeutics, Inc. (the “Company”) will host a conference call on May 17, 2023 at 8:00 a.m. eastern time. During this conference call, the Company expects to discuss the results from its Phase 3 registration-directed clinical trial of sepiapterin for phenylketonuria. Directions on how to access the conference call are included in the press release furnished as Exhibit 99.1 hereto. A copy of the slide deck that will be presented during the conference call is furnished as Exhibit 99.2 hereto.
The information in this Item 7.01 of this Current Report on Form 8-K (“Report”), including Exhibits 99.1 and 99.2, shall not be deemed “filed” for 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 under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. All website addresses given in this Report or incorporated herein by reference are for information only and are not intended to be an active link or to incorporate any website information into this Report.
Item 8.01. Other Events.
On May 17, 2023, the Company announced that the primary endpoint was achieved in its Phase 3 registration-directed clinical trial of sepiapterin in adult and pediatric patients with phenylketonuria.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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| Exhibit No. | Description | |
| 99.1 | | Press Release, dated May 17, 2023 issued by PTC Therapeutics, Inc. |
| 99.2 | | Corporate Presentation – APHENITY Topline Results |
| 104 | | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
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.
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| | PTC Therapeutics, Inc. | |
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| Date: May 17, 2023 | By: | /s/ Emily Hill |
| | Name: | Emily Hill |
| | Title: | Chief Financial Officer |
EXHIBIT 99.1 PTC Therapeutics Announces APHENITY Trial Achieved Primary Endpoint with Sepiapterin in PKU Patients
- Highly statistically significant and clinically meaningful results -
- 63% mean blood Phe reduction in primary analysis population (p<0.0001) -
- Conference call and webcast to be held at 8:00 AM EDT -
SOUTH PLAINFIELD, N.J., May 17, 2023 -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the primary endpoint was achieved in the APHENITY, Phase 3 registration-directed clinical trial of sepiapterin in adult and pediatric patients with phenylketonuria (PKU).
“The positive results from the APHENITY trial bring us one step closer to providing a therapy that could deliver meaningful benefit to PKU patients,” said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. “The Phe reductions observed in the placebo-controlled portion of the study are consistent with, and, in some cases, exceed the magnitude of Phe reductions recorded in the open label portion of the study. We look forward to meeting with regulatory authorities to discuss the path to approval.”
The placebo-controlled portion of the study included 98 patients in the primary analysis population. The mean percent Phe reduction in sepiapterin treated patients was 63%. In the subset of classical PKU patients, the mean percent Phe reduction was 69%. Minimal reductions in Phe levels were observed in the placebo treated patients resulting in a highly statistically significant sepiapterin treatment benefit (p<0.0001). Sepiapterin was generally well tolerated with no serious adverse events.
Today's Conference Call and Webcast PTC will hold a conference call at 8 AM EDT today to discuss this news. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations. A replay of the call will be available approximately two hours after completion of the call and will be archived on the company's website for 30 days following the call.
About APHENITY
APHENITY was a global double-blind, placebo-controlled, registration-directed study which enrolled 156 children and adults with PKU. Participants were randomized to receive sepiapterin or placebo for six weeks with the primary endpoint being reduction in blood phenylalanine levels. The trial consisted of two parts. Part 1 was a run-in phase, during which all screened subjects received sepiapterin for two weeks. Only those subjects who demonstrated a reduction in phenylalanine levels of 15% or more from baseline in Part 1 were randomized to receive either sepiapterin or placebo in Part 2 of the clinical trial. The primary analysis population consists of those who had greater than 30% reduction in phenylalanine levels from baseline during Part 1 of the trial. The primary outcome measure is the reduction of blood phenylalanine levels from baseline compared to Weeks 5 and 6 in patients from Part 2 of the clinical trial. All patients are eligible to enroll in an open label long term clinical trial designed to further evaluate the long-term safety and durable effect of sepiapterin.
About Sepiapterin
Sepiapterin (formerly PTC923) is an oral formulation of synthetic sepiapterin, a precursor to intracellular tetrahydrobiopterin, which is a critical enzymatic cofactor involved in the metabolism and synthesis of numerous metabolic products. Sepiapterin is a more bioavailable precursor than exogenously administered synthetic BH4 and has the potential to treat the broad range of PKU patients.
About Phenylketonuria
Phenylketonuria (PKU) is a rare, inherited metabolic disease, which affects the brain.^1^ It is caused by a defect in the gene that helps create the enzyme needed to break down phenylalanine.^1^ If left untreated or poorly managed, phenylalanine – an essential amino acid found in all proteins and most foods – can build up to harmful levels in the body. This causes severe and irreversible disabilities, such as permanent
intellectual disability, seizures, delayed development, memory loss, and behavioral and emotional problems.^1^Newborns with phenylketonuria initially don’t have any symptoms, but symptoms are usually progressive, and damage caused by toxic levels of phenylalanine in the first few years of life is irreversible.^2,3^Diagnosis of phenylketonuria usually takes place during newborn screening programs.^4^There are an estimated 58,000 people with phenylketonuria globally.
About PTC Therapeutics, Inc.
PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC's ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC's mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC's strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients. PTC believes this allows it to maximize value for all its stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, Instagram, LinkedIn and Twitter at @PTCBio.
For More Information:
Investors:
Kylie O'Keefe
+1 (908) 300-0691
kokeefe@ptcbio.com
Media:
Jeanine Clemente
+1 (908) 912-9406
jclemente@ptcbio.com
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historic fact, are forward-looking statements, including statements with respect to the future expectations, plans and prospects for PTC, including with respect to the expected timing of clinical trials and studies, availability of data, regulatory submissions and responses and other matters, future operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words, "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.
PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward -looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or product candidates that PTC commercializes or may commercialize in the future; expectations with respect to potential regulatory submissions and commercialization of sepiapterin for phenylketonuria, or PKU, and potential development and regulatory milestone payments that PTC may be obligated to make with regards to sepiapterin, expectations with respect to the COVID-19 pandemic and related response measures and their effects on PTC's business, operations, clinical trials, regulatory submissions and approvals, and PTC's collaborators, contract research organizations, suppliers and manufacturers; significant business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial potential of sepiapterin for PKU; PTC's scientific approach and general development progress; the sufficiency of PTC's cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures; and the factors discussed in the "Risk Factors" section of PTC's most recent Annual Report on Form 10-
K, as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully consider all such factors.
As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including sepiapterin.
The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this presentation except as required by law.
References:
| 1. | de Groot MJ, Hoeksma M, Blau N, et al. Mol Genet Metab 2010;99:S86–S89. |
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| 2. | Phenylketonuria (PKU). Available at: https://www.mayoclinic.org/diseases-conditions/phenylketonuria/symptoms-causes/syc-20376302. Accessed October 2021. |
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| 3. | Blau N, van Spronsen FJ, Levy HL. Lancet 2010;376:1417–1427. |
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| 4. | Al Hafid N, Christodoulou J. Transl Pediatr 2015;4(4):304–317. |
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Exhibit 99.2
| Patient Living<br>with PKU<br>Matthew Klein, M.D.<br>CEO<br>May, 2023<br>APHENITY<br>Topline Results |
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| Forward-Looking Statements<br>2<br>This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this<br>presentation, other than statements of historic fact, are forward-looking statements, including statements with respect to the future expectations, plans and prospects for<br>PTC, including with respect to the expected timing of clinical trials and studies, availability of data, regulatory submissions and responses and other matters, future<br>operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words,<br>"guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.<br>PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward -looking statements it makes as a result of a variety<br>of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or<br>product candidates that PTC commercializes or may commercialize in the future; expectations with respect to potential regulatory submissions and commercialization of<br>sepiapterin for phenylketonuria, or PKU, and potential development and regulatory milestone payments that PTC may be obligated to make with regards to<br>sepiapterin, expectations with respect to the COVID-19 pandemic and related response measures and their effects on PTC's business, operations, clinical trials, regulatory<br>submissions and approvals, and PTC's collaborators, contract research organizations, suppliers and manufacturers; significant business effects, including the effects of<br>industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial<br>potential of sepiapterin for PKU; PTC's scientific approach and general development progress; the sufficiency of PTC's cash resources and its ability to obtain adequate<br>financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures; and the factors discussed in the "Risk Factors" section of PTC's<br>most recent Annual Report on Form 10 -K, as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully<br>consider all such factors.<br>As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no<br>guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including sepiapterin.<br>The forward-looking statements contained herein represent PTC's views only as of the date of this presentation and PTC does not undertake or plan to update or revise<br>any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after<br>the date of this presentation except as required by law.<br>APHENITY Topline Results |
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| APHENITY Topline Results Demonstrate Clinical<br>and Statistically Significant Benefit<br>3<br>Achieved primary endpoint in<br>placebo-controlled portion of<br>study with statistically<br>significant (p<0.0001) blood<br>phenylalanine (Phe) reduction<br>Demonstrated substantial<br>Phe reduction in both the<br>overall primary analysis<br>population (63%) and the<br>subset of classical PKU<br>patients (69%)<br>Achieved Phe reduction<br>sufficient to bring 84% of study<br>patients within US guidelines for<br>Phe reduction <360 µmol/L<br>Well tolerated with no serious<br>adverse events<br>APHENITY Topline Results |
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| APHENITY Global Registration-Directed<br>Trial of Sepiapterin Study Design<br>4<br>Primary Endpoint<br>Reduction in blood<br>phenylalanine levels<br>Primary Endpoint<br>Sepiapterin<br>Placebo<br>42 Days<br>Placebo-Controlled<br>Sepiapterin<br>Run-in<br>Part 1 Part 2<br>R<br>14 Days<br>APHENITY Topline Results |
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| -70%<br>-60%<br>-50%<br>-40%<br>-30%<br>-20%<br>-10%<br>0%<br>Overall Classical PKU<br>APHENITY Part 1 Results Demonstrated<br>Marked Blood Phe Reductions<br>5<br>Mean Absolute Blood Phe Reduction (µmol/L)<br>≥30% responders<br>Mean % Blood Phe Reduction<br>≥30% responders<br>Mean % Blood Phe<br>Reduction<br>Mean Absolute Blood Phe<br>Reduction (µmol/L)<br>N=103 N=16<br>60%<br>66%<br>-600<br>-500<br>-400<br>-300<br>-200<br>-100<br>0<br>Overall Classical PKU<br>N=103 N=16<br>586<br>464<br>APHENITY Topline Results |
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| APHENITY Study Population<br>6<br>Sepiapterin-Responsiveness<br>Evaluated in<br>156 patients<br>Patients <2 age<br>2 patients*<br>Not randomized<br>3 patients<br>Primary<br>Analysis<br>Population<br>98 patients<br>12 Patients with<br>≥15 – <30% Reduction<br>110 randomized<br>patients<br>Responders<br>≥30% Reduction in<br>Blood Phe from Baseline<br>103 patients<br>66%<br>APHENITY Topline Results<br>*As per protocol this population entered directly into open label extension |
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| APHENITY Global Registration-Directed<br>Trial of Sepiapterin Study Design<br>7<br>Primary Endpoint<br>Sepiapterin<br>Placebo<br>42 Days<br>Placebo-Controlled<br>Sepiapterin<br>Run-In<br>Part 1 Part 2<br>R<br>14 Days Stratification<br>Mean percent reduction in<br>blood Phe levels from Part 1<br>(≥30% or ≥15 - <30% )<br>Baseline blood Phe level<br>(<600 µmol/L or ≥600 µmol/L)<br>APHENITY Topline Results |
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| 8<br>APHENITY Primary Analysis Population Includes<br>Full Spectrum of PKU Patients<br>APHENITY Topline Results<br>Baseline Characteristic Sepiapterin (N=49) Placebo (N=49)<br>Mean age at enrollment (yrs) [min, max] 16.3 [2, 47] 18.1 [4, 54]<br>2-17 (%) 34 (69.4) 31 (63.3)<br>≥18 years (%) 15 (30.6) 18 (36.7)<br>Sex: %F, %M F: 46.9<br>M: 53.1<br>F: 55.1<br>M: 44.9<br>Mean Baseline Blood Phe (µmol/L)<br>(min, max) 646.1 (179.5, 1350.0) 654.0 (289.5, 1650.0)<br>Mean Baseline Blood Phe<br>in Classical PKU (µmol/L)<br>(min, max)<br>761.25 (452.0, 1350.0) 771.56 (317.0, 1240.0) |
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| Sepiapterin Treatment Resulted in Clinically<br>Significant Blood Phe Reduction<br>9 APHENITY Topline Results<br>Mean % Blood Phe Reduction<br>-70<br>-60<br>-50<br>-40<br>-30<br>-20<br>-10<br>0<br>10<br>Sepiapterin<br>Overall Primary Analysis Population Classical PKU Patients<br>Mean % Blood Phe<br>Reduction<br>Mean % Blood Phe<br>Reduction<br>N=49<br>63% 586<br>464<br>1%<br>N=49<br>-70<br>-60<br>-50<br>-40<br>-30<br>-20<br>-10<br>0<br>10<br>Sepiapterin Placebo<br>N=6<br>69%<br>3%<br>N=9<br>(p<0.0001) (p<0.001)<br>Placebo |
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| -600<br>-500<br>-400<br>-300<br>-200<br>-100<br>0<br>Sepiapterin Placebo<br>Sepiapterin Treatment Resulted in Clinically<br>Significant Blood Phe Reduction<br>10<br>-600<br>-500<br>-400<br>-300<br>-200<br>-100<br>0<br>Sepiapterin Placebo<br>Overall Primary Analysis Population Classical PKU Patients<br>Mean Absolute Blood Phe<br>Reduction (µmol/L)<br>Mean Absolute Blood Phe<br>Reduction (µmol/L)<br>N=49<br>410<br>586<br>16<br>N=49<br>-416<br>523<br>42<br>N=9<br>APHENITY Topline Results<br>Mean Absolute Blood Phe Reduction (µmol/L)<br>N=6<br>(p<0.0001) (p<0.001) |
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| EU guidelines: ≥12 years of age<br>Vast Majority of Patients Achieved Guidelines<br>Target Blood Phe Levels<br>11<br>93%<br>Achieved<br><600µmol/L<br>Blood Phe<br>US guidelines: all ages<br>EU guidelines: <12 years of age<br>84%<br>Achieved<br><360µmol/L<br>Blood Phe<br>APHENITY Topline Results |
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| Sepiapterin Part 1 Treatment Effect in Patients<br>Receiving Sapropterin at Study Entry<br>12<br>800<br>700<br>600<br>500<br>400<br>300<br>200<br>100<br>0<br>Mean Blood Phe (µmol/L)<br>(N=27 patients)<br>Mean blood Phe on<br>sapropterin (µmol/L)<br>at study entry<br>Mean blood Phe (µmol/L)<br>following 7-day washout<br>Mean blood Phe (µmol/L)<br>on sepiapterin in Part 1<br>APHENITY Topline Results<br>48%<br>lower Phe levels<br>following sepiapterin<br>treatment in those<br>patients receiving<br>sapropterin at study<br>entry<br>Guideline<br>Target |
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| Sepiapterin Demonstrated to be Well Tolerated<br>13<br>Most common adverse events<br>were headache and diarrhea<br>Sepiapterin was well tolerated with<br>no serious adverse events<br>Similar related adverse event frequency between<br>sepiapterin and placebo treatment groups<br>APHENITY Topline Results |
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| APHENITY Open-Label Extension Assesses<br>Long Term Safety and Phe Tolerance<br>14<br>R<br>Sepiapterin<br>Placebo<br>42 Days<br>Placebo-Controlled Open-Label Extension<br>Sepiapterin<br>1 Year<br>Sepiapterin<br>Run-in<br>Part 1 Part 2<br>Study Objectives<br>Long-term safety<br>Change in dietary<br>Phe/protein consumption<br>14 Days<br>APHENITY Topline Results |
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| 0<br>20<br>40<br>60<br>80<br>100<br>120<br>140<br>M1 W1-W2 (BL)<br>M2 W1-W2<br>M2 W3-W4<br>M3 W5-W6<br>M3 W7-W8<br>M4 W9-W10<br>M4 W11-W12<br>M5 W13-W14<br>M5 W15-W16<br>M6 W17-W18<br>M6 W19-W20<br>M7 W21-W22<br>Initial Phe Tolerance Data in Open-Label Extension<br>15 APHENITY Topline Results Prescribed Phe Consumption (mg/kg/day)<br>Adult recommended<br>Phe intake<br>(N=12) (N=4)<br>0<br>50<br>100<br>150<br>200<br>250<br>300<br>M1 W1-W2 (BL)<br>M1 W3-W4<br>M2 W1-W2<br>M3 W5-W6<br>M4 W9-W10<br>M5 W13-W14<br>M6 W17-W18<br>M7 W21-W22<br>Mean Blood Phe<br>(µmol/L)<br>(N=12) (N=4)<br>Increase in Dietary Phe Intake Blood Phe Levels |
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| Commercial Pillars for Success Already Established<br>16<br>Newborn<br>screening with<br>~58,000 patients<br>worldwide1,2,3<br>Well-known<br>metabolic centers<br>of excellence<br>worldwide<br>Connected and<br>coordinated<br>patient advocacy<br>community<br>Disease pathology<br>well understood<br>and documented<br>APHENITY Topline Results 1. NPKUA; https://www.npkua.org/, 2. Shoraka et. Al, Clin Exp Pediatr. 2020; 63(2): 34–43., 3. Borrajo G., Acta Ped Mex. 2012; 33(6): 279-287. |
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| APHENITY Results Support Potential for Sepiapterin<br>to Address Majority of PKU Segments<br>17 APHENITY Topline Results<br>Sepiapterin<br>Market<br>Opportunity<br>Therapy Naive<br>Patients Including<br>Classical PKU<br>Patients Who Are<br>Not Well Controlled<br>Patients Who<br>Have Failed on<br>Current Therapies |
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| PTC Global Commercial Infrastructure Will<br>Allow for Rapid Worldwide Launch<br>18<br>KOL/ Payor<br>Relationships<br>PAG Relationships<br>Patient<br>Support<br>Dedicated<br>Customer Facing<br>Teams<br>EAP/<br>Access &<br>Reimbursement<br>Plug and Play in PKU<br>APHENITY Topline Results |
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| APHENITY Results Support Next Steps in<br>Regulatory Process and Commercial Planning<br>19<br>Pre-Submission<br>Meetings<br>Regulatory<br>Submissions<br>APHENITY Topline Results<br>Initiate Launch<br>Preparation |
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