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Orum Therapeutics Announces $30 Million Series B Financing to Advance Cell-Penetrating, Cell-Specific Antibody Technology for Novel Therapeutics

On July 17, 2019 Orum Therapeutics reported an oversubscribed $30 million Series B financing. New investors, IMM Investment, Smilegate Investment, KTB Network, and Stassets Investment, join existing investors, InterVest and KB Investment/Solidus Investment in the financing (Press release, Orum Therapeutics, JUL 17, 2019, View Source [SID1234537556]). The proceeds of the financing will be used to expand Oromab, Orum’s proprietary cell-specific, cell-penetrating antibody platform technology that targets "undruggable" proteins and delivers a variety of therapeutic payloads. The company is applying the Oromab platform to discover and develop novel therapeutics for cancer and rare diseases, both internally and with partners. The financing will also further expand Orum’s R&D labs in Korea and Boston, where the company was recently accepted into a biotech incubator in Kendall Square, Cambridge.

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"A large number of important therapeutic targets are currently considered ‘undruggable,’ making drug discovery for these targets technically challenging," said Sung Joo Lee, Ph.D., Founder and CEO of Orum Therapeutics. "By intracellular delivery of antibodies, our platform redefines what undruggable means."

Using the Oromab platform, Orum builds antibodies that bind cell-specific receptors and are internalized through receptor-mediated endocytosis. With Orum’s proprietary design, these antibodies escape the early endosome into the cytosol. Once in the cytosol, the antibodies can be therapeutically active and directly target disease-causing proteins or deliver payloads. With the Oromab platform, Orum is exploring several therapeutic avenues: 1) inhibiting Ras and tumor-specific intracellular oncogenic drivers, 2) delivery of oligonucleotides or enzymes for cancer and rare diseases, and 3) targeted degradation of disease proteins.

"Orum’s cell-penetrating antibody platform is unique in that, it has the capacity to not only transform the landscape of druggable targets, but also overcome the limitation of cytosolic delivery of other therapeutic modalities," said Peter Park, Ph.D., Chief Scientific Officer of Orum Therapeutics.

Cytori Will Become Plus Therapeutics, Inc.

On July 16, 2019 Cytori Therapeutics, Inc. (Nasdaq: CYTX) (the "company") reported a new direction and identity (Press release, Cytori Therapeutics, JUL 16, 2019, View Source [SID1234572285]).

Since the beginning of 2019, the company has successfully evaluated and transformed its pipeline to place a stronger emphasis on product candidates that can maximize returns for shareholders and make a clinically meaningful impact for patients. Plus Therapeutics, Inc. plans to create and realize this value by developing drugs for niche and orphan markets, initially in oncology, that address significant unmet or substantially underserved medical needs and that represent global revenue opportunities estimated to be $250 million or more. We intend to focus our development activities in ways that can leverage the U.S. FDA’s accelerated regulatory pathways and enable the company to apply its in-house expertise in nanoparticle drug design, complex formulation, and drug manufacturing and scale-up.

"Our core development concept will be to combine known active pharmaceutical ingredients, or drugs, with new delivery approaches and/or formulations, resulting in innovative therapies with improved safety, efficacy, and/or convenience," said Marc H. Hedrick MD, President and CEO.

The company’s initial development focus will be on DocePLUS (formerly ATI-1123) — a complex, injectable, patented, albumin-stabilized pegylated liposomal docetaxel — for which a U.S. Phase 1 clinical trial has been completed and published. The company has previously announced that it has received feedback from the U.S. FDA that a 505(b)(2) new drug application appears to be an acceptable regulatory approach for DocePLUS. Plus Therapeutics intends to submit a Phase 2 clinical trial protocol in Small Cell Lung Cancer patients with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy to the U.S. FDA in the second half of 2019.

Coinciding with this new focus on DocePLUS, the company has determined that DoxoPLUS (formerly ATI-0918) –- a generic pegylated liposomal doxorubicin — no longer satisfies the aforementioned development and revenue criteria. As a result, we have elected to focus on divesting DoxoPLUS and are currently presenting this opportunity to external parties.

To complement and reinforce the new company direction, a new company brand will be established. We have created, designed, and launched a new company visual identity, mission, vision, values, website, and social media sites based on the brand promise of ‘Delivering More For Patients’.

"We took a holistic approach to branding the company under the new Plus Therapeutics name," said Russ Havranek, Vice President, Marketing and Portfolio Management. "We believe that Plus Therapeutics will clearly align, drive, and navigate the business forward, ultimately helping patients who are battling cancer and other life-threatening diseases."

The company has reserved a new stock symbol, PSTV, and plans to submit notice of the company name change to the Nasdaq Stock Exchange. We expect to trade under the new symbol within the next few weeks. Until then, the company intends to continue to trade on Nasdaq under its current stock symbol, CYTX.

X4 Pharmaceuticals and Abbisko Therapeutics Enter into Oncology Development and Commercialization Agreement for Mavorixafor in Greater China

On July 16, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, and Abbisko Therapeutics, a company with an extensive pipeline of targeted therapeutics with first-in-class or best-in-class potential, reported they have entered into an agreement to develop and commercialize X4’s product candidate, mavorixafor, in combination with checkpoint inhibitors or other agents in Greater China for oncology indications. Mavorixafor is a potentially first-in-class, once-daily, oral, small molecule antagonist of chemokine receptor CXCR4 (Press release, Abbisko Therapeutics, JUL 16, 2019, View Source;article_id=104 [SID1234556282]).

This agreement provides Abbisko with the exclusive rights in China, Taiwan, Hong Kong and Macau to develop and commercialize maxorixafor in combination with checkpoint inhibitors or other agents in oncology indications – including pancreatic cancer, ovarian cancer and triple negative breast cancer, which will be explored initially. X4 retains full rest-of-world rights to develop and commercialize mavorixafor outside of Greater China for all indications, and the ability to utilize any data generated pursuant to the Abbisko collaboration for rest-of-world development.

"We are pleased to enter into this strategic partnership with the experienced team at Abbisko. This collaboration enables us to leverage Abbisko’s research and development expertise to explore mavorixafor’s potential benefit in advanced cancer patients and to potentially capture value from the growing oncology markets in Greater China, while enabling X4 to maintain its focus on the company’s ongoing rare disease programs," commented Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. "Abbisko’s top-notch investor syndicate, strong leadership with global oncology R&D experience, and broad healthcare network in Greater China provide a complementary opportunity to expand mavorixafor’s potential for patients into solid tumor oncology indications, which represent areas of significant unmet need."

"Mavorixafor has demonstrated proof of concept and a favorable safety profile in a Phase 2 trial in patients with WHIM syndrome, which is caused by compromised immune cell trafficking. We look forward to further realizing mavorixafor’s potential in broad oncology indications in combination with immune checkpoint inhibitors and other therapies, for the benefit of patients with significant unmet medical needs," said Dr. Yaochang Xu, Chief Executive Officer of Abbisko Therapeutics. "Targeting CXCR4 has strong mechanistic rationales in oncology and we believe mavorixafor will bring transformative value to Abbisko’s portfolio with clear synergies with our internal pipeline programs."

About Mavorixafor

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), and clear cell renal cell carcinoma (ccRCC).

Gilead Sciences to Release Second Quarter 2019 Financial Results on Tuesday, July 30, 2019

On July 16, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its second quarter 2019 financial results will be released on Tuesday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the second quarter 2019 and provide a business update (Press release, Gilead Sciences, JUL 16, 2019, View Source [SID1234537572]).

The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 8696029 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, August 1, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 8696029. The webcast will be archived on www.gilead.com for one year.

Melinta Therapeutics Announces Preliminary Second Quarter 2019 Financial Results and Provides Corporate Update

On July 16, 2019 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, reported preliminary and unaudited financial results and provided a corporate update for the second quarter ended June 30, 2019 (Press release, Cempra, JUL 16, 2019, View Source [SID1234537564]).

"Melinta’s preliminary second quarter 2019 results demonstrate that the actions taken to improve upon the Company’s operational and financial efficiencies are continuing to drive progress," said John H. Johnson, chief executive officer of Melinta. "As we enter into the third quarter of 2019, we remain focused on driving sales efforts, preparing for the potential Baxdela (delafloxacin) community-acquired bacterial pneumonia (CABP) approval and launch, while also continuing to identify additional ways to reduce expenses. We believe in the strength of our long-term strategy to best position Melinta for future success and remain committed to delivering upon our mission of leading the global fight against antimicrobial resistance and providing antibiotic solutions to patients and healthcare providers."

Preliminary Second Quarter 2019 Financial Results
Melinta anticipates that it will report net product sales of approximately $13.8 million for the second quarter of 2019, which is an increase of 51 percent over the second quarter of 2018 and an increase of 17 percent over the first quarter of 2019.

Melinta also expects to report quarter-end cash and cash equivalents of approximately $90 million, and the Company is targeting to reduce full-year 2019 operating expenses by approximately $70 million.

The figures in the foregoing sentences are all based upon preliminary estimates and remain subject to change as the Company finalizes its results for the second quarter of 2019.
The Company will announce its full second quarter 2019 financial results on August 7, 2019 at 8:30 a.m. ET and plans to host a conference call at that time.

Recent Corporate Updates

On July 10, The World Health Organization (WHO) added Vabomere (meropenem and vaborbactam) to its Essential Medicines List for its ability to target multidrug-resistant infections caused by pathogens deemed a "critical priority" by the WHO, including carbapenem-resistant Enterobacteriaceae

The U.S. Food and Drug Administration (FDA) recently accepted for priority review a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP); the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019

Sixteen scientific presentations and posters of portfolio and pipeline data have been accepted for presentation at the Infectious Diseases Society of America IDWeek 2019 meeting, being held October 1 – 6, 2019 in Washington, D.C. and at the American College of Chest Physicians (ACCP) CHEST Meeting, being held October 19 – 23, 2019 in New Orleans, LA

Second Quarter 2019 Conference Call and Webcast
Melinta’s earnings conference call for the second quarter of 2019 will be broadcast at 8:30 a.m. ET on August 7, 2019. Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151, using the conference ID# 5166674. A live webcast of the call will be available online from the Investor Relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID# 5166674.