By creator to www.globenewswire.com
NEW YORK and VIENNA, Austria, Could 14, 2020 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), an organization growing a brand new class of immunotherapeutics focusing on infectious ailments and cancers primarily based on its proprietary arenavirus platform, right this moment stories its monetary outcomes and company replace for the primary quarter ended March 31, 2020.
“The present unusually difficult occasions are impacting our business considerably. HOOKIPA continues to progress nicely in areas that are beneath our management,” commented Joern Aldag, HOOKIPA’s Chief Government Officer. “The HOOKIPA workforce is continuous to activate websites for our oncology candidate HB-201 and sufferers are accruing. We anticipate to submit the mixed HB-202/201 IND to the U.S. Meals and Drug Administration within the first half of 2020, as beforehand forecasted. For HB-101, though enrollment of kidney transplant sufferers is at the moment hampered by the influence of COVID-19, we anticipate to report preliminary security and immunogenicity knowledge in July 2020 and efficacy knowledge by the tip of 2020, roughly on the identical time we anticipate to report preliminary security and efficacy for HB-201. With roughly $105 million in money and money equivalents, we consider that we’re nicely funded past a number of medical knowledge factors throughout our packages. As well as, I’m notably pleased with the outstanding contribution of the HOOKIPA workforce voluntarily accepting a big discount of their fastened salaries and thereby extending our money runway.”
R&D Pipeline Replace and Medical Progress
HB-101, lead product candidate in infectious ailments
HOOKIPA’s VaxWave®-based prophylactic Cytomegalovirus (CMV) vaccine candidate, HB‑101, is in a randomized, double‑blinded Section 2 medical trial in sufferers awaiting kidney transplantation who’re in danger for CMV-associated problems post-transplant. As a result of COVID-19 pandemic, practically all ongoing Section 2 trial websites have suspended affected person enrollment, and it stays unclear when kidney organ transplants will resume at any of the trial websites.
By the tip of July 2020, HOOKIPA expects to report security knowledge (on roughly one-third of the full 150 sufferers to be enrolled) in addition to immunogenicity knowledge (on roughly one-quarter of the full sufferers to be enrolled). The immunogenicity knowledge will concentrate on CMV-neutralizing antibody responses. Analyses of mobile immune responses, together with CD8+ T cells, have been restricted thus far as a result of complexities of pattern assortment, transport, and evaluation. HOOKIPA reiterates its steerage to ship preliminary efficacy knowledge by the tip of 2020. As a result of COVID-19-impacted accrual, the timing of examine completion will probably be delayed.
HB-201 and HB-202, packages for the therapy of Human Papillomavirus-positive cancers
HOOKIPA’s lead oncology product candidates, HB‑201 and HB‑202, are in improvement for the therapy of Human Papillomavirus‑constructive (HPV+) cancers. In December 2019, HOOKIPA initiated the Section 1/2 medical trial for HB-201 and expects preliminary ends in late 2020 or early 2021. The open label, dose escalating Section 1/2 medical trial is evaluating HB-201 in HPV16+ cancers, alone and together with an accepted checkpoint inhibitor. HOOKIPA plans to enroll 100 sufferers in complete with 20 sufferers in every dose escalation and growth group, respectively. Enrollment of the primary group of sufferers receiving the intravenously administered first dose degree has been accomplished and the trial is accruing sufferers on the subsequent larger dose degree.
HOOKIPA stays on observe to file the HB‑202/201 Preliminary New Drug (IND) submission with the U.S. Meals and Drug Administration within the first half of 2020. The deliberate medical trial combining HB-202 with HB-201, additionally in sufferers with HPV16+ cancers, is an open label, dose escalation Section 1/2 trial with the first endpoint to judge security and tolerability. That trial is predicted to start later in 2020.
Gilead Sciences Collaboration for HIV and HBV Therapeutic Vaccines
Throughout 2019, HOOKIPA acquired $6.0 million in milestone funds from Gilead for the supply of analysis vectors and for advancing the packages in the direction of medical trials. Primarily based on preclinical knowledge generated thus far, Gilead dedicated to preparations to advance the HBV and HIV vectors towards improvement, with the HBV improvement resolution triggering a milestone fee of $4.0 million, which the Firm acquired in early 2020. To allow the event actions and expanded analysis packages, Gilead agreed to order manufacturing capability and enhance reimbursement budgeted for the Firm’s expanded sources allotted to the Gilead collaboration.
At HOOKIPA’s New York Metropolis headquarters, all staff will proceed to make money working from home and are totally operational. The Austrian authorities has eliminated a number of the beforehand mandated COVID-19 restrictions that it put in place throughout March 2020, and this has allowed HOOKIPA’s Austrian web site to ramp up its actions. The Firm plans to extend its lab capability to the extent secure and affordable, and on the identical time encourages all staff who can moderately make money working from home to proceed to take action.
First Quarter 2020 Monetary Outcomes
HOOKIPA’s money, money equivalents and restricted money as of March 31, 2020 was $104.9 million in comparison with $113.6 million as of December 31, 2019. The lower was primarily attributable to money utilized in working actions.
Income was $3.7 million for the three months ended March 31, 2020 in comparison with $2.2 million for the three months ended March 31, 2019. Income was pushed by the popularity of milestone funds and partial recognition of the upfront fee in addition to price reimbursements acquired beneath the Collaboration Settlement with Gilead.
Analysis and Improvement Bills:
HOOKIPA’s analysis and improvement bills had been $11.5 million for the three months ended March 31, 2020 in comparison with $10.2 million for the three months ended March 31, 2019.
The first drivers of this enhance had been $1.Three million larger personnel bills together with a normal enhance in inside analysis and improvement bills, partially offset by an total lower in direct analysis and improvement bills by $0.6 million. The latter discount was a consequence of lowered exercise round our earlier stage packages; as well as, preparation prices of medical trials for our HB-201 and HB-202 packages had been decrease than in the identical interval final 12 months. This lower was partially offset by a rise within the direct prices associated to our collaboration with Gilead as a consequence of an acceleration program and a modest enhance in direct bills for the HB-101 Section 2 trial.
Common and Administrative Bills: Common and administrative bills amounted to $4.6 million for the three months ended March 31, 2020 in comparison with $2.7 million for the three months ended March 31, 2019. The rise was primarily as a consequence of personnel associated bills, a rise in skilled and consulting charges, in addition to prices associated to being a public firm, akin to premiums for administrators and officers legal responsibility insurance coverage.
Web Loss: HOOKIPA’s web loss was $10.9 million for the three months ended March 31, 2020 in comparison with a web lack of $9.3 million for the three months ended March 31, 2019. This enhance was pushed by larger analysis and improvement bills, particularly for HOOKIPA’s oncology packages, and a rise typically and administrative bills following HOOKIPA’s IPO.
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a medical stage biopharmaceutical firm growing a brand new class of immunotherapeutics focusing on infectious ailments and cancers primarily based on its proprietary arenavirus platform that’s designed to reprogram the physique’s immune system.
HOOKIPA’s proprietary arenavirus-based applied sciences, VaxWave®, a replication-deficient viral vector, and TheraT®, a replication-attenuated viral vector, are designed to induce sturdy antigen particular CD8+ T cells and pathogen-neutralizing antibodies. Each applied sciences are designed to permit for repeat administration to enhance and refresh immune responses. TheraT® has the potential to induce CD8+ T cell response ranges beforehand not achieved by different immuno-therapy approaches. HOOKIPA’s “off-the-shelf” viral vectors goal dendritic cells in vivo to activate the immune system.
HOOKIPA’s VaxWave®-based prophylactic Cytomegalovirus (CMV) vaccine candidate is at the moment in a Section 2 medical trial in CMV-negative sufferers awaiting kidney transplantation from residing CMV-positive donors in addition to CMV-positive sufferers awaiting kidney transplantation from CMV-positive or -negative donors. To broaden its infectious illness portfolio, HOOKIPA has entered right into a collaboration and licensing settlement with Gilead Sciences, Inc. to collectively analysis and develop practical cures for HIV and continual Hepatitis B infections.
As well as, HOOKIPA is constructing a proprietary immuno-oncology pipeline by focusing on virally mediated most cancers antigens, self-antigens and next-generation antigens. The TheraT® primarily based lead oncology product candidates, HB-201 and HB-202, are in improvement for the therapy of Human Papilloma Virus 16-positive cancers. The Section 1/2 medical trial for HB-201 was initiated in December 2019. The HB-202 IND submission is meant for the primary half of 2020.
Discover out extra about HOOKIPA on-line at www.hookipapharma.com.
HOOKIPA Ahead Trying Statements
Sure statements set forth on this press launch represent “forward-looking” statements inside the that means of the Non-public Securities Litigation Reform Act of 1995, as amended. Ahead-looking statements could be recognized by phrases akin to “believes,” “expects,” “plans,” “potential,” “would” or comparable expressions and the adverse of these phrases. Such forward-looking statements contain substantial dangers and uncertainties that would trigger HOOKIPA’s analysis and medical improvement packages, future outcomes, efficiency or achievements to vary considerably from these expressed or implied by the forward-looking statements. Such dangers and uncertainties embrace, amongst others, the uncertainties inherent within the drug improvement course of, together with HOOKIPA’s packages’ early stage of improvement, the method of designing and conducting preclinical and medical trials, the regulatory approval processes, the timing of regulatory filings, the challenges related to manufacturing drug merchandise, HOOKIPA’s capability to efficiently set up, defend and defend its mental property, dangers referring to enterprise interruptions ensuing from the coronavirus (COVID-19) illness outbreak or comparable public well being crises, the influence of COVID-19 on the enrollment of sufferers and timing of medical outcomes for HB-101 and different packages, and different issues that would have an effect on the sufficiency of present money to fund operations and HOOKIPA’s capability to realize the milestones beneath the settlement with Gilead. HOOKIPA undertakes no obligation to replace or revise any forward-looking statements. For an extra description of the dangers and uncertainties that would trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers referring to the enterprise of the corporate typically, see HOOKIPA’s quarterly report on Kind 10-Q for the quarter ended March 31, 2020 which is obtainable on the Safety and Alternate Fee’s web site at www.sec.gov and HOOKIPA’s web site at www.hookipapharma.com.
Traders and others ought to observe that we announce materials monetary info to our traders utilizing our investor relations web site (https://ir.hookipapharma.com/), SEC filings, press releases, public convention calls and webcasts. We use these channels, in addition to social media, to speak with our members and the general public about our firm, our providers and different points. It’s potential that the data we submit on social media may very well be deemed to be materials info. Subsequently, we encourage traders, the media, and others excited by our firm to evaluation the data we submit on the U.S. social media channels listed on our investor relations web site.
HOOKIPA Pharma Inc.
Consolidated Statements of Operations (Unaudited)
(In hundreds, besides share and per share knowledge)
|Three months ended March 31,|
|Income from collaboration and licensing||$||3,696||$||2,235|
|Analysis and improvement||(11,526||)||(10,179||)|
|Common and administrative||(4,629||)||(2,711||)|
|Whole working bills||(16,155||)||(12,890||)|
|Loss from operations||(12,459||)||(10,655||)|
|Whole curiosity, different earnings and taxes, web||1,533||1,326|
|Web loss per share — fundamental and diluted||(0.43||)||(9.27||)|
|Weighted common widespread shares excellent — fundamental and diluted||25,630,007||1,006,595|
Condensed Stability Sheets (Unaudited)
|As of||As of|
|March 31,||December 31,|
|Money, money equivalents and restricted money||$||104,877||$||113,575|
|Whole stockholders’ fairness||108,982||117,899|
For additional info, please contact:
Senior Director – Communications
Government Director – Investor Relations
+44 (0)20 7457 2020