Gemphire Therapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Update
“2019 is shaping up to be a year of transition for us. On
Proposed Merger with NeuroBo Highlights
- Immediately following the merger, Gemphire security holders are expected to own 4.06% of the post-merger company and NeuroBo security holders are expected to own 95.94% of the post-merger company on a fully-diluted basis (subject to adjustment based on Gemphire’s net cash balance and the amount of additional financing proceeds received by NeuroBo above the minimum required amount and up to and including
- Pre-closing financing by NeuroBo with approximately
$24 millionof gross proceeds already received.
- The merger includes contingent value rights (CVRs) for existing Gemphire stockholders entitling them to receive certain cash payments in the event the gemcabene assets are sold or licensed during the CVR period.
- The post-merger company will be led by
John L. Brooks, III, President & CEO of NeuroBo, and the post-merger Board of Directors will be 6 directors, including Steven Gullans, Ph.D., Gemphire’s current President & CEO.
- The merger is expected to close in the second half of 2019, subject to the approval of the stockholders of each company, as well as other closing conditions.
Beijing SL Outlicensing Partnership Highlights
- In exchange for the rights to gemcabene, Gemphire will receive an upfront payment of
$2.5 millionas well as potential future milestone payments and royalties if certain development and commercialization milestones are met.
- Beijing SL has committed to pursue a Phase 3 clinical trial program for patients with Homozygous Familial Hypercholesterolemia and potentially other indications in
- The Beijing SL deal expands the future possibilities to advance gemcabene into the Chinese market.
Second Quarter 2019 Corporate Highlights
- Announced top-line results of Proof-of-Concept (POC) Phase 2 trial investigating gemcabene in Familial Partial Lipodystrophy Disease (FPLD)
- Gemcabene treatment resulted in a median change in serum triglycerides (TG) of -19.6% for the five patients at twelve weeks (the primary endpoint). The range of TG responses was +40.4 % to -52.9%, with three patients showing decreases.
- Secondary endpoints included measurement of liver fat fraction by MRI-PDFF which showed reduction in 2 of the 3 responding patients.
- Four patients completed treatment and a fifth one discontinued at 22 weeks (with data carried forward as 24 weeks).
- Gemcabene appeared to be generally safe and well-tolerated in these five patients. There was one serious adverse event of benign paroxysmal positional vertigo, considered unrelated to gemcabene.
- FPLD is considered an orphan indication and represents a large clinical unmet need.
- Continued activities to address
FDArequests related to the partial clinical hold
- In Q3 2018, Gemphire’s request to the
FDAto lift the partial clinical hold on gemcabene was denied and the FDArequested additional information in order to resubmit.
- Gemphire is currently collecting and collating additional information including a subchronic (13 week) study of gemcabene in PPARα knockout mice and a study of gemcabene in in vitro PPAR transactivation assays using monkey and canine PPAR isoforms.
- Gemphire expects to submit additional information to the
FDAin the fourth quarter of 2019 to request that it lift the partial clinical hold, assuming the proposed merger is consummated in a timely fashion.
- In Q3 2018, Gemphire’s request to the
Second Quarter 2019 Financial Update
General and administrative expenses for the three and six months ended
Research and development expenses for the three and six months ended
Net loss attributable to common stockholders for the second quarter ended
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH. The Company is focused on providing new treatment options for cardiometabolic diseases through its complementary, convenient, cost-effective product candidate gemcabene as add-on to the standard of care, especially statins that will benefit patients, physicians, and payors. Gemphire’s Phase 2 clinical program is evaluating the efficacy and safety of gemcabene in hypercholesterolemia, hypertriglyceridemia and fatty liver disease, including FH, SHTG, NASH/NAFLD, and ASCVD. Two trials supporting hypercholesterolemia and one trial in SHTG have been completed under NCT02722408, NCT02634151 and NCT02944383, respectively. Please visit www.gemphire.com for more information.
Important Additional Information Will be Filed with the
In connection with the proposed transaction between Gemphire and NeuroBo, the parties intend to file relevant materials with the
Investors and shareholders will be able to obtain free copies of the proxy
statement/prospectus/information statement and other documents filed by Gemphire with the
No Offer or Solicitation
This communication shall not constitute an offer to sell, the solicitation of an offer to sell or an offer to buy or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Participants in the Solicitation
Gemphire, and its directors and executive officers, and NeuroBo, and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from the stockholders of Gemphire in connection with the proposed merger. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the proxy statement / prospectus / information statement referred to above. Additional information about Gemphire’s directors and executive officers is included in Gemphire’s Annual Report on Form 10-K for the year that ended
Forward Looking Statements
Any statements in this press release that are not statements of historical fact, including statements about Gemphire’s future expectations, milestones, goals, plans and prospects, such as statements about the proposed merger and other contemplated transactions (including statements relating to satisfaction of the conditions to and consummation of the proposed merger, the expected ownership of the combined company and the belief that the proposed merger and licensing partnership with Beijing SL will provide value to Gemphire stockholders), potential payments under the CVRs, the ability of Gemphire or the post-merger combined company to submit data to the
LifeSci Advisors, LLC
Condensed Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
|For the Three Months Ended||For the Six Months Ended|
|June 30,||June 30,|
|General and administrative||$||1,115||$||2,574||$||2,522||$||4,661|
|Research and development||1,234||3,960||2,627||8,937|
|Total operating expenses||2,349||6,534||5,149||13,598|
|Loss from operations||(2,349||)||(6,534||)||(5,149||)||(13,598||)|
|Interest (expense) income||10||(144||)||(820||)||(304||)|
|Loss before income taxes||(2,920||)||(6,678||)||(6,721||)||(13,902||)|
|Provision (benefit) for income taxes||—||—||—||—|
|Other comprehensive loss, net of tax||—||—||—||—|
|Net loss per share:|
|Basic and diluted (Note 9)||$||(0.20||)||$||(0.47||)||$||(0.47||)||$||(1.04||)|
|Number of shares used in per share calculations:|
|Basic and diluted||14,265,411||14,232,313||14,265,411||13,340,941|
Balance Sheet Data
|June 30,||December 31,|
|Cash and cash equivalents||$||3,643||$||18,954|
|Total current assets||3,988||19,686|
|Term loan (current portion)||—||9,437|
|Total stockholders’ equity||1,964||7,774|
Source: Gemphire Therapeutics Inc.