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 2.02 Results of Operations and Financial Condition.
On August 15, 2022, Inozyme Pharma, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2022. 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:
Exhibit |
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Description |
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99.1 104 |
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Press Release issued by the Company on August 15, 2022 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 thereunto duly authorized.
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INOZYME PHARMA, INC. |
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Date: |
August 15, 2022 |
By: |
/s/ Axel Bolte |
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Name: Axel Bolte |
Exhibit 99.1
Inozyme Pharma Reports Second Quarter 2022 Financial Results and Provides Business Updates
- Recently reported positive preliminary biomarker and safety data from ongoing Phase 1/2 clinical trials of INZ-701 in ENPP1 Deficiency and ABCC6 Deficiency –
- Appointed Kurt Gunter, M.D. as senior vice president and chief medical officer -
- Secured flexible debt facility for up to $70 million -
- Cash, cash equivalents and investments as of quarter end, together with first tranche of debt facility, funds cash flow requirements into the second quarter of 2024 –
BOSTON, August 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 second quarter ended June 30, 2022 and provided recent business highlights.
“I am pleased with the increasing momentum in our clinical development and the strength of our balance sheet to deliver important data milestones across our clinical trials in patients with ENPP1 Deficiency and ABCC6 Deficiency,” said Axel Bolte, MSc, MBA, Inozyme’s co-founder, president and chief executive officer. “We recently reported positive preliminary data in our Phase 1/2 trial of INZ-701 in patients with ABCC6 Deficiency, providing the first evidence that INZ-701 increased PPi levels in subjects with functional ENPP1 enzyme, which we believe potentially opens the possibility to expand to additional indications that are characterized by low levels of PPi. We look forward to presenting data from the higher dose cohorts in the Phase 1/2 trial of INZ-701 in ABCC6 Deficiency.”
Recent Clinical Trial Updates
Recent Corporate Updates
Second Quarter 2022 Financial Results
About ENPP1 Deficiency
ENPP1 Deficiency is a progressive condition that manifests as a spectrum of diseases. Individuals who present in utero or in 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 50% of infants with ENPP1 Deficiency die within six months of birth. Children with ENPP1 Deficiency typically experience rickets, a condition also known as autosomal-recessive hypophosphatemic rickets type 2 (ARHR2), while adults experience osteomalacia (softened bones), and they can exhibit a range of signs and symptoms that include hearing loss, arterial calcification, and cardiac and/or 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 affects more than 67,000 individuals worldwide. Infants with ABCC6 Deficiency are diagnosed with generalized arterial calcification of infancy (GACI) type 2, a condition that resembles GACI type 1, the infant form of ENPP1 Deficiency. In older individuals, ABCC6 Deficiency presents as pseudoxanthoma elasticum (PXE), which is characterized by pathological mineralization in blood vessels and soft tissues clinically affecting the skin, eyes, and vascular system. There are no approved therapies for ABCC6 Deficiency.
About INZ-701
INZ-701 is a clinical-stage enzyme replacement therapy in development for the treatment of mineralization disorders of the circulatory system, bones, and kidneys. In preclinical studies, the experimental therapy has shown potential to generate PPi and to restore it to appropriate physiological levels, thereby preventing calcification in the vasculature and kidneys, while at the same time normalizing bone mineralization. Inozyme is developing INZ-701 for certain rare, life-threatening, and devastating genetic disorders such as ENPP1 Deficiency and ABCC6 Deficiency in which PPi levels are below the normal physiological levels. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and 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 Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 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 timing of our ongoing and planned clinical trials and other studies, the availability of data from clinical trials, the potential benefits of INZ-701, the impact of the debt facility on the Company’s balance sheet and the sufficiency of the Company's cash resources. 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 conduct its ongoing 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 and Quarterly Report on Form 10-Q 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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June 30, |
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December 31, |
Cash, cash equivalents and investments |
$ 151,480 |
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$ 111,801 |
Total assets |
$ 161,989 |
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$ 123,541 |
Total liabilities |
$ 12,813 |
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$ 14,273 |
Additional paid-in-capital |
$ 329,414 |
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$ 256,948 |
Accumulated deficit |
$ (179,845) |
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$ (147,700) |
Total stockholders' equity |
$ 149,176 |
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$ 109,268 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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2022 |
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2021 |
Operating expenses: |
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Research and development |
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$ 10,007 |
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$ 8,220 |
General and administrative |
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5,384 |
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4,435 |
Total operating expenses |
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15,391 |
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12,655 |
Loss from operations |
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(15,391) |
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(12,655) |
Other income (expense): |
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Interest income |
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321 |
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58 |
Other (expenses) income |
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(191) |
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57 |
Other income, net |
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130 |
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115 |
Net loss |
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$ (15,261) |
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$ (12,540) |
Other comprehensive (loss) income: |
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Unrealized (losses) gains on available-for-sale securities |
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(225) |
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6 |
Foreign currency translation adjustment |
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(43) |
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— |
Total other comprehensive (loss) income |
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(268) |
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6 |
Comprehensive loss |
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$ (15,529) |
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$ (12,534) |
Net loss attributable to common stockholders—basic |
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$ (15,261) |
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$ (12,540) |
Net loss per share attributable to common |
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$ (0.38) |
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$ (0.53) |
Weighted-average common shares and pre-funded warrants outstanding—basic and diluted |
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39,703,550 |
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23,490,591 |
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Six Months Ended June 30, |
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2022 |
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2021 |
Operating expenses: |
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Research and development |
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$ 21,821 |
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$ 14,823 |
General and administrative |
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10,409 |
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8,804 |
Total operating expenses |
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32,230 |
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23,627 |
Loss from operations |
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(32,230) |
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(23,627) |
Other income (expense): |
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Interest income |
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381 |
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121 |
Other expense |
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(296) |
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(84) |
Other income, net |
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85 |
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37 |
Net loss |
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$ (32,145) |
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$ (23,590) |
Other comprehensive (loss) income: |
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Unrealized (losses) gains on available-for-sale securities |
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(357) |
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16 |
Foreign currency translation adjustment |
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(58) |
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— |
Total other comprehensive (loss) income |
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(415) |
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16 |
Comprehensive loss |
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$ (32,560) |
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$ (23,574) |
Net loss attributable to common stockholders—basic |
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$ (32,145) |
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$ (23,590) |
Net loss per share attributable to common |
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$ (1.01) |
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$ (1.01) |
Weighted-average common shares and pre-funded warrants outstanding—basic and diluted |
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31,739,197 |
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23,460,218 |
Contacts
Investors:
Inozyme Pharma
Stefan Riley, Director of Investor Relations
(857) 330-8871
stefan.riley@inozyme.com
Media:
SmithSolve
Matt Pera
(973) 886-9150
matt.pera@smithsolve.com