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Elevation files for $100M IPO to fund tumor-agnostic candidate

On June 7, 2021 Elevation Oncology reported that it has filed to raise $100 million in an IPO (Press release, Elevation Oncology, JUN 7, 2021, View Source [SID1234583792]). The money will support development of an anti-HER3 antibody that failed multiple trials at Merrimack Pharmaceuticals before being picked up by Elevation and repositioned as a treatment for solid tumors harboring an NRG1 fusion.

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The antibody, seribantumab, failed multiple midphase trials, causing Sanofi to return the rights to the drug and ultimately leading to Merrimack offloading it to Elevation in 2019. Elevation picked up the molecule after identifying HER3 inhibition as an approach for tumors driven by an NRG1 fusion. In preclinical tests, HER3 inhibition led to reductions of growth for NRG1 fusion-driven tumors.

"We believe that direct inhibition of the NRG1 activation of HER3 with a monoclonal antibody approach may drive improved responses for these patients given its direct role in sustaining proliferation and survival of tumors harboring an NRG1 fusion," Elevation wrote in its IPO paperwork.

Elevation raised almost $100 million across series A and B rounds from investors including Aisling Capital, venBio Partners and Cormorant Asset Management, giving it the means to start a phase 2 clinical trial. Now, the biotech is seeking public investment for further development of seribantumab.

If successful, Elevation believes the phase 2 may support a filing for FDA approval. The 55-subject pivotal cohort of the study is enrolling patients with a centrally confirmed NRG1 fusion who haven’t been previously treated with an EGFR-, HER2- or HER3-directed therapy. The primary endpoint is the overall response rate.

Elevation sees other ERBB or HER3 inhibitors in development at companies including Merus, Rain Therapeutics, Hummingbird Bioscience, GamaMabs Pharma and AVEO Oncology as the key rivals to seribantumab. Other companies such as Daiichi Sankyo, GlaxoSmithKline and Boehringer Ingelheim are working on similar drugs, but Elevation is unsure whether they are targeting NRG1 fusion tumors.

Ambrx, a San Diego-Shanghai Biotech, Files for $100 Million US IPO

On June 7, 2021 Ambrx, a San Diego clinical-stage biotech with operations in Shanghai, reported that it has filed for a US IPO that is expected to raise $100 million (Press release, Ambrx, JUN 7, 2021, View Source [SID1234583791]). Founded in 2003, Ambrx develops antibody-drug conjugates and bispecifics for unmet oncology needs. It builds engineered precision biologics by incorporating synthetic amino acids (SAAs) into proteins within living cells, a technology that offers better efficacy and safety, according to the company. Its lead drug, an ADC candidate, is being tested in a China Phase II/III trial for HER2-positive metastatic breast cancer led by a China partner, NovoCodex Biopharma.

MSD Animal Health to Acquire Assets of LIC Automation Ltd.

On June 7, 2021 MSD Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE:MRK), reported its intention to acquire the assets of LIC Automation Ltd. ("LICA"), from New Zealand-based, farmer-owned cooperative Livestock Improvement Corporation Ltd. ("LIC") (Press release, Merck & Co, JUN 7, 2021, View Source [SID1234583738]). LICA is a leader in automation and technology for the dairy industry. Specific terms of the agreement were not disclosed.

LICA, a privately held company in New Zealand, manufactures and supplies specialised, integrated herd management systems and milk-testing sensors for the dairy industry. Farm productivity has become increasingly important on the dairy farm. LICA’s automated offerings including Protrack technology solutions, enables dairy farmers to gather precise information on the health and milking habits of dairy cows, which supports their efforts in herd management, real-time milk analysis, animal evaluation and reproductive health and wellness. LICA products are available in New Zealand and in selected European markets.

"We are pleased to take this step forward with the acquisition of LICA technology, as we continue to broaden our portfolio with complementary products and technologies to advance animal well-being and outcomes for our customers," said Rick DeLuca, president, MSD Animal Health. "Our portfolio of enhanced dairy farm management and livestock intelligence solutions for the dairy industry help address the evolving customer needs of dairy farmers and strengthen our leadership in shaping the future of animal health."

"We are excited to add LICA’s products to our existing veterinary medicines, vaccines and health management solutions and services, as well as Allflex Livestock Intelligence’s digitally connected identification, traceability and monitoring products to benefit farmers and veterinarians," said Pauline Calvert, Livestock Business Unit lead, MSD Animal Health, New Zealand. "MSD Animal Health has a substantial footprint in New Zealand as a leading partner in the agricultural community. The solutions we offer build upon our strong presence in New Zealand, which includes manufacturing facilities at Palmerston North (Allflex Livestock Intelligence, a business unit within MSD Animal Health), Upper Hutt (animal health vaccines) and now Hamilton (LICA milking intelligence and automation). We are exceptionally proud of our continuous commitment and investment to advance animal health and well-being for our unique pastoral-based farming systems in Aotearoa (New Zealand), that supports the efforts of our farmers’ in their day-to-day operations today and into the future. We look forward to continuing to expand our world-class animal health solutions both locally and globally."

LICA’s product portfolio joins Allflex Livestock Intelligence, the leading New Zealand livestock intelligence business. Allflex Livestock Intelligence is a complementary business that specialises in identification and monitoring technology that delivers real-time, actionable data and insights to help improve livestock management.

"We are pleased that MSD Animal Health has chosen to acquire this technology," said Wayne McNee, LIC chief executive. "MSD Animal Health has a reputation for investing heavily in research and development for animal health and welfare. The company has extensive scientific and technological capabilities that can take this technology to the next phase and deliver more value to farmers."

Galapagos increases share capital through subscription right exercises

On June 7, 2021 Galapagos NV (Euronext & NASDAQ: GLPG) reported a share capital increase arising from subscription right exercises (Press release, Galapagos, JUN 7, 2021, View Source [SID1234583710]).

Galapagos issued 10,940 new ordinary shares on 7 June 2021, for a total capital increase (including issuance premium) of €325,279.

Pursuant to the subscription right exercise program of Galapagos’ management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, one management board member exercised 5,000 subscription rights.

In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €354,418,623.11, the total number of securities conferring voting rights amounts to 65,522,521, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 6,709,662 subscription rights under several outstanding employee subscription right plans, which equals 6,709,662 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. This excludes the 2,736,250 subscription rights of Subscription Right Plan 2021 BE, Subscription Right Plan 2021 RMV and Subscription Right Plan 2021 ROW, which were created subject to acceptance. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

Cerecor Enters Into $35 Million Debt Financing Agreement With Horizon Technology FinanceFiling

On June 7, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, reported that it has entered into a debt financing agreement led by Horizon Technology Finance Corporation (NASDAQ: HRZN) ("Horizon") to provide up to $35.0 million in term loans (Press release, Cerecor, JUN 7, 2021, View Source [SID1234583693]).

"We are pleased to partner with Horizon, a leading specialty finance company that has an extensive history of supporting innovative life science companies," said Michael Cola, Chief Executive Officer of Cerecor. "Over the course of 2021, we anticipate a number of important data readouts across our immunology, oncology, and rare genetic disorders product candidates. This transaction immediately strengthens and extends our financial resources to advance our clinical pipeline towards these key development milestones."

Gerald A. Michaud, President of Horizon stated, "We are delighted to provide this financing to Cerecor and have confidence in the Company’s business strategy. We look forward to watching the Company reach its critical development milestones for its orphan and rare disease therapies in the pipeline. This investment in Cerecor provides another example of our ability to finance life sciences companies through multiple stages of development and through various value inflection points."

$20 million of the $35 million loan was funded upon closing. The remaining $15 million may be funded upon Cerecor achieving certain predetermined milestones. Each advance of the loan will be repaid in 42 monthly payments consisting of 18 monthly payments of interest only, followed by 24 monthly payments of principal and accrued interest, and will be payable monthly in arrears. The interest-only period may be extended to 24 months contingent upon Cerecor achieving certain milestones. In connection with the financing, Cerecor issued Horizon warrants to purchase up to 403,844 of its common shares at an exercise price of $2.60 per share. Proceeds will be used to support the ongoing clinical development of key investigational product candidates within its pipeline and for general working capital purposes.

Jefferies acted as exclusive arranger and financial advisor to Cerecor in this transaction.