UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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 2.02 Results of Operations and Financial Condition.
On March 15, 2022, Inozyme Pharma, Inc. (the “Company”) announced its financial results for the year ended December 31, 2021. The full text of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02, including Exhibit 99.1 attached hereto, 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 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 a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
The following exhibit is furnished herewith:
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Exhibit No. |
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Description |
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99.1 104 |
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Press Release issued by the Company on March 15, 2022 Cover Page Interactive Data File (embedded within 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 thereunto duly authorized.
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INOZYME PHARMA, INC. |
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Date: |
March 15, 2022 |
By: |
/s/ Axel Bolte |
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Name: Axel Bolte |
Exhibit 99.1
Inozyme Pharma Reports Full Year 2021 Financial Results and Provides Business Highlights
– Phase 1/2 trial of INZ-701 in adult patients with ENPP1 Deficiency underway -
– Preliminary safety and biomarker data from Phase 1/2 trials in ENPP1 Deficiency and ABCC6 Deficiency on track for the first half of 2022 –
BOSTON, MARCH 15, 2022 – Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today reported financial results for the full year ended December 31, 2021, and provided recent business highlights.
“2021 was a transformational year for Inozyme, as we continued to progress our INZ-701 program and graduated to a clinical-stage company. We initiated our first clinical trial for patients with ENPP1 Deficiency and are screening patients for our clinical trial in ABCC6 Deficiency, and have continued to deepen our understanding of the pathophysiology of these rare and devastating mineralization disorders,” said Axel Bolte, MSc, MBA, Inozyme’s co-founder, president, and chief executive officer. “We firmly believe that INZ-701 could be a meaningful intervention in patients with ENPP1 Deficiency and ABCC6 Deficiency, and we are committed to realizing the full potential of this promising therapy.”
Recent Updates
Upcoming Anticipated Milestones
The Company also announced the following anticipated milestones for the INZ-701 clinical development program, subject to COVID-19-related restrictions:
Financial Result for the Year Ended December 31, 2021
About ENPP1 Deficiency
ENPP1 Deficiency is a progressive condition that manifests as a spectrum of diseases. Those who present in utero or infancy are typically diagnosed with generalized arterial calcification of infancy (GACI), which is characterized by extensive vascular calcification and neointimal proliferation (overgrowth of smooth muscle cells inside blood vessels), resulting in myocardial infarction, stroke, or cardiac or multiorgan failure. Approximately 45% to 50% of infants with ENPP1 Deficiency die within 6 months of birth. Children and adults with ENPP1 Deficiency typically experience rickets and osteomalacia (softened bones), also termed autosomal-recessive hypophosphatemic rickets type 2 (ARHR2), and can exhibit a range of signs and symptoms that can include hearing loss, arterial calcification, cardiac, and neurological involvement. There are no approved therapies for ENPP1 Deficiency.
About ABCC6 Deficiency
ABCC6 Deficiency is a rare, severe, inherited disorder caused by mutations in the ABCC6 gene, leading to low levels of PPi. PPi is essential for preventing harmful soft tissue calcification and regulating bone mineralization. ABCC6 Deficiency is a systemic and progressively debilitating condition, which we believe affects more than 67,000 individuals worldwide. The condition is characterized by pathological mineralization in blood vessels and soft tissues throughout the body that can drive devastating medical problems. Some infants with ABCC6 Deficiency are diagnosed with generalized arterial calcification of infancy (GACI) type 2, a vascular condition that resembles GACI type 1, the acute infantile form of ENPP1 Deficiency. In older patients, ABCC6 Deficiency presents as pseudoxanthoma elasticum (PXE), a rare, inherited disorder in which individuals develop calcification of soft connective tissues, including in the eyes, cardiovascular system, and skin. There are no approved therapies for ABCC6 Deficiency.
About Inozyme Pharma
Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6 Deficiencies.
INZ-701 is currently in a Phase 1/2 clinical trial for ENPP1 Deficiency. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D., Ph.D., and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University. For more information, please visit www.inozyme.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation and timing of our clinical trials, trial design, the availability of clinical trial data and the potential benefits of INZ-701. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company's ability to initiate and conduct its ongoing and planned Phase 1/2 clinical trials of INZ-701 for ENPP1 Deficiency and ABCC6 Deficiency; obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section in the Company's most recent Annual Report on Form 10-K filed with the
Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.
Condensed Consolidated Balance Sheet Data
(Unaudited)
(in thousands)
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December 31, 2021 |
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December 31, 2020 |
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Cash, cash equivalents and investments |
$ |
111,801 |
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$ |
159,896 |
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Total assets |
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123,541 |
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169,363 |
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Total liabilities |
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14,273 |
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11,260 |
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Additional paid-in-capital |
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256,948 |
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249,175 |
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Accumulated deficit |
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(147,700) |
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(91,076) |
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Total stockholders' equity |
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109,268 |
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158,103 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
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Year Ended |
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December 31, |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
$ |
37,720 |
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$ |
46,493 |
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General and administrative |
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18,926 |
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10,548 |
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Total operating expenses |
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56,646 |
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57,041 |
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Loss from operations |
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(56,646) |
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(57,041) |
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Other income: |
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Interest income |
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211 |
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370 |
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Other income (expense), net |
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(189) |
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247 |
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Other income, net |
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22 |
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617 |
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Net loss |
$ |
(56,624) |
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$ |
(56,424) |
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Other comprehensive (loss) income: |
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Unrealized losses on available-for-sale securities |
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(4) |
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(3) |
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Foreign currency translation adjustment |
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20 |
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— |
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Total other comprehensive income (loss) |
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16 |
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(3) |
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Comprehensive loss |
$ |
(56,608) |
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$ |
(56,427) |
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Net loss attributable to common stockholders—basic |
$ |
(56,624) |
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$ |
(56,424) |
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Net loss per share attributable to common |
$ |
(2.40) |
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$ |
(5.11) |
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Weighted-average common shares outstanding—basic |
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23,558,306 |
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11,036,500 |
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Contacts
Investors:
Inozyme Pharma
Stefan Riley, Director of Investor Relations
stefan.riley@inozyme.com
Media:
SmithSolve
Matt Pera
(973) 886-9150
matt.pera@smithsolve.com