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Histogenics Corporation Announces Financial and Operating Results for the Fourth Quarter and Year Ended December 31, 2017
NeoCart® Top-line Phase 3 Clinical Trial Data and Potential Biologics License Application Filing Remain on Track for Third Quarter of 2018
NeoCart Licensing Agreement with
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“We achieved multiple, significant milestones in our global development strategy for NeoCart in 2017, providing a strong foundation for additional value creation in 2018. With the completion of enrollment in the NeoCart Phase 3 clinical trial in the first half of 2017, we are on track to report top-line data from this trial and potentially submit a Biologics License Application for this novel restorative cell therapy in the third quarter of 2018. In parallel we are initiating pre-commercialization activities for the U.S. market in advance of a potential launch of NeoCart in fourth quarter of 2019, and we continue to hear positive anecdotal feedback from our investigators regarding NeoCart patients,” stated
2017 and Recent Milestones
NeoCart Clinical, Regulatory and Commercialization
- Completed enrollment for NeoCart Phase 3 clinical trial: In
June 2017, Histogenicsenrolled the final patient for its 249-patient Phase 3 randomized, controlled clinical trial conducted against the current standard of care, microfracture. The trial is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration(the FDA).
- Executed licensing agreement for the development and commercialization of NeoCart in
Japanwith MEDINET Co., Ltd.(MEDINET): In December 2017, Histogenicsentered into an agreement with MEDINET, a pioneering leader in the development and commercialization of cancer immuno-cell therapy technologies, for the development and commercialization of NeoCart for the Japanese market. The agreement included a $10 millionup-front payment, potential total payments of up to $87 millionin total milestones and tiered royalties on sales. MEDINET intends to initiate NeoCart clinical development in Japanin the second half of 2018, and may enter the Japanese market in 2021, if approved.
- Completed formal discussions with the
Japan Pharmaceuticalsand Medical Devices Agency(PMDA) to establish the development/regulatory pathway for NeoCart in Japan: Histogenicssuccessfully concluded formal discussions with the PMDA in the second quarter of 2017. Feedback from the PMDA was positive and included the determination that a 30-patient, one-year confirmatory clinical trial with Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japanin conjunction with data from Histogenics’ fully enrolled U.S. Phase 3 clinical trial. Additionally, the PMDA agreed that NeoCart would be regulated as a Regenerative Medicine Product, as covered by the recently enacted laws in Japan, and that Histogenicsmay supply the confirmatory clinical trial from the U.S. using the current good manufacturing processes (cGMP) for NeoCart.
- Confirmed significant unmet need in cartilage repair through U.S. and Japan NeoCart market research:
Histogenicsconducted primary market research in the U.S. and Japanwith approximately 200 orthopedic and sports medicine surgeons across both markets. The findings provide support for Histogenics’ assumptions regarding the size of each market, the lack of satisfactory solutions, and confirm the need for a novel cartilage repair therapy. Surgeons noted a strong desire for a safe and effective alternative to microfracture that may potentially offer patients a more rapid recovery from pain and return to function as well as a durable treatment response.
- Generated additional peer-reviewed data that may support the upcoming NeoCart regulatory submissions and highlight the potential of Histogenics’ RCT platform: The published results included analyses of the compressive properties of engineered cartilage tissue grown with chondrocytes seeded in a porous scaffold in a study titled “In Vitro Culture Increases Mechanical Stability of Human Tissue Engineered Cartilage Constructs by Prevention of Microscale Scaffold Buckling,” which appeared in the peer-reviewed
Journal of Biomechanics. In addition, a study appearing in the Journal of Orthopaedic Researchentitled “ Mechanical Propertiesand Structure-Function Relationships of Human Chondrocyte-Seeded Cartilage Constructs After In Vitro Culture” evaluated 3-D bioprinting of collagen and chondrocytes. These studies may support both process optimization and a potential Biologics License Application (BLA) filing for NeoCart, as well as the future development of additional product candidates based on the RCT technology platform.
- Podium and poster presentations at
Orthopedic Research Society(ORS) Annual Meeting: Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital (BWH), and Harvard Medical School, delivered a podium presentation on NeoCart and Histogenics’ RCT technology platform at the ORS Annual Meeting on March 10, 2018. In addition, three additional poster presentations on NeoCart were presented during the meeting. Data presented on these posters are available here.
- Enhanced executive team ahead of potential approval and commercialization of NeoCart: In
October 2017, Histogenicspromoted Stephen Kennedyfrom Chief Technology Officer to Executive Vice President & Chief Operating Officer. In June 2017, Donald Hautwas appointed Chief Business Officer. Both individuals possess strong professional experience that will be instrumental as Histogenicsprepares for potential NeoCart commercial manufacturing and launch.
- Completed registered direct financing: In
January 2018, Histogenicsraised net proceeds of $5.9 million dollarsfrom a registered direct offering of its common stock. The proceeds from the offering provided an important source of additional funding and flexibility in advance of a potential NeoCart BLA filing.
2018 Corporate Objectives
- Report NeoCart top-line Phase 3 data and submit BLA: Assuming positive results from the report of top-line superiority data from the NeoCart Phase 3 clinical trial in the third quarter of 2018,
Histogenicsremains positioned to submit a BLA with the FDAthereafter in the third quarter of 2018.
- Continue advancement of NeoCart U.S. commercialization strategy: In advance of potential
FDAapproval of NeoCart, Histogenicsintends to continue to prepare for a potential NeoCart launch in the U.S., including the assembly of a leading Clinical Advisory Board, the further development of marketing and reimbursement strategies and the initial development of sales and medical science liaison territories.
- Leverage collaborations to generate and publish additional data to support BLA and foreign regulatory filings and potential U.S. commercialization of NeoCart:
Histogenicsexpects to continue to generate data from its collaborations with BWH, Cornell University(Cornell) and Intrexon Corporation(Intrexon). Anticipated presentations and publications in 2018 include additional biomechanical and three-dimensional printing data from the collaboration with Cornell, the use of chondrocytes to develop new products to treat additional soft-tissue and musculoskeletal-related disorders from the collaboration with BWH and proof-of-concept data from studies combining Intrexon’s induced Pluripotent Stem Cell (iPSC) technology and Histogenics’ NeoCart platform to manufacture next generation, NeoCart restorative cell therapies using iPSC-derived chondrocytes.
- Secure additional manufacturing capacity: Subject to positive top-line data from the NeoCart Phase 3 clinical trial,
Histogenicsintends to initiate the design and buildout of additional space to support expected increased commercial manufacturing requirements in future years following the initial launch of NeoCart.
- Support MEDINETS’
Japanclinical trial and regulatory activities: Histogenicsis working closely with MEDINET on the development of NeoCart for the Japanese market. Specifically, the companies intend to work on the preparation of a clinical trial notification to support the planned NeoCart Phase 3 clinical trial in Japanin the second half of 2018. In addition, Histogenicsintends to continue to explore additional licensing opportunities for NeoCart outside of North America.
Financial Results for the Year Ended
Histogenics’ loss from operations was
Research and development expenses were
Basic net loss attributable to common stockholders was
Conference Call and Webcast Information
To access a live audio webcast of the presentation on the “Investor Relations” page of the
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart clinical development in
There can be no assurance that the actual results or developments anticipated by
All written and verbal forward-looking statements attributable to
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||3,366||5,317||15,566||21,577|
|General and administrative||2,667||2,389||9,384||8,530|
|Impairment of intangible asset||‒||200||–||200|
|Total operating expenses||6,033||7,906||24,950||30,307|
|Loss from operations||(6,033||)||(7,906||)||(24,950||)||(30,307||)|
|Other income (expense):|
|Interest income (expense), net||20||(5||)||134||(60||)|
|Other income (expense), net||25||50||(116||)||(248||)|
|Change in fair value of warrant liability||(808||)||16,968||(1,482||)||17,507|
|Total other income (expense), net||(763||)||16,969||(1,464||)||14,099|
|Net Income (loss)||$||(6,796||)||$||9,063||$||(26,414||)||$||(16,208||)|
|Net Income (loss) attributable to common stockholders|
|Net Income (loss) per common share:|
|Weighted-average shares used to compute earnings (loss) per common share:|
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
|December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||7,981||$||31,908|
|Prepaid expenses and other current assets||194||173|
|Property and equipment, net||2,723||3,860|
|Other assets, net||137||137|
|Warrant and other non-current liabilities||18,498||17,340|
|Total stockholders’ equity (deficit)||(11,268||)||13,567|
|Total liabilities and stockholders’ equity (deficit)||$||11,035||$||36,078|
Contact: Investor Relations Tel: +1 (781) 547-7909 InvestorRelations@histogenics.com