Finance Watch: NDA-Ready Impact Gets Commitment For Another $90m

Start-up Impact's new structured financing – its second fundraising event this month – will pay out in increments as fedratinib nears the market. Also, Ablynx closed its $200m US IPO; Chi-Med follow-on brings in $262m; and VCs gives Cydan $34m to launch new companies.

Impact Biomedicines has closed a structured financing for up to $90m – just two weeks after launching with $22.5m in venture capital – that will support commercialization of its JAK2 inhibitor fedratinib, a drug the company's executives reacquired from Sanofi.

Medicxi Ventures provided San Diego-based Impact's initial funding, which will be used to seek approval and prepare for commercial manufacturing of fedratinib, assuming the US FDA does not require an additional study before a new drug application (NDA) can be filed (see sidebar). The new funding comes from Oberland Capital, which initially will provide two $20m milestone-based payments in exchange for royalties from fedratinib sales. Impact can draw down another $35m to $50m upon FDA approval to finance the drug's launch and commercialization.

CEO John Hood was director of research and co-inventor of fedratinib at the drug's original developer, TargeGen Inc. He left TargeGen in 2008 – after Sanofi committed to buying the firm, but two years before the transaction closed. (Also see " Sanofi-Aventis to pay up to $560 million for single product TargeGen " - Scrip, 30 Jun, 2010.) However, Sanofi ended development of fedratinib after the drug was put on clinical hold due to cases of Wernicke's encephalopathy – a condition that Impact and now FDA believes could be overcome with closer monitoring of patients. (Also see " Sanofi kills PhIII JAK2 inhibitor on safety grounds" - Scrip, 18 Nov, 2013.)

President and Chief Business Officer Charlie McDermott said in a statement from the company that the Oberland financing "will provide Impact incremental financing as it is needed and gives us flexibility with regard to our commercial strategy for fedratinib without the need for a large dilutive upfront capital raise."

The financing and royalty agreement with Oberland also takes off any pressure Impact may have had to do a deal to bring fedratinib to market, though the company has been moving forward with the intention of commercializing the drug on its own, Hood told Scrip earlier this month. He noted, however, that Impact may partner with a third party if the companies' priorities are aligned.

Ablynx Completes IPO With $230m Gross

Ablynx NV had one of the largest US initial public offerings this year when it raised $230m from the sale of 13.14m American depository shares (ADSs), including shares set aside for overallotments, at $17.50 each in an offering that closed on Oct. 27. (Also see "Ablynx Ups Profile Stateside With $200m Nasdaq Listing" - Scrip, 25 Oct, 2017.) Ablynx will use the cash to fund drugs developed with its Nanobody platform, including caplacizumab, which recently succeeded in the Phase III HERCULES trial in the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). (Also see "Caterpillar To Butterfly? Ablynx Says Caplacizumab Data Transformational" - Scrip, 2 Oct, 2017.)

Austin, Texas-based Genprex Inc., which is developing gene therapies to treat cancer, launched into the US stock market on Oct. 13 with an offering of 2.5m to 4.5m shares priced at $5 each to raise at least $12.5m and up to $22.5m. The company's lead product candidate is Oncoprex immunogene therapy for non-small cell lung cancer (NSCLC). (Also see "Pipeline Watch: Phase III Trials In Prostate Cancer, Diffuse Large B-cell Lymphoma" - Scrip, 13 Jan, 2017.) The IPO proceeds will fund an ongoing Phase II NSCLC study and initiation of a Phase I/II trial in combination with another immunotherapy.

Updates from other IPO hopefuls include:

• Burlington, Mass.-based scPharmaceuticals Inc. filed paperwork with the US Securities and Exchange Commission (SEC) on Oct. 23 to register its intention to raise up to $100m in a future IPO. The company raised a $46.5m Series B venture capital round at the start of 2017 to fund commercial preparations for bringing Furoscix, a diuretic treatment for heart failure, and the sc2Wear Infusor, a patch pump device for subcutaneous administration, to market in the US, and to continue development of its antibiotic pipeline, which is what scPharmaceuticals intends to do with its IPO proceeds as well. (Also see "VC Roundup: Infectious Disease Startup Snags $150m And Former Biogen CEO Scangos" - Scrip, 8 Jan, 2017.)
• Arsanis Inc. registered its IPO intentions with the SEC on Oct. 20, revealing that it plans to raise up to $57.5m in a future offering. The Waltham, Mass.-based company closed a $45.5m Series D round earlier this year to fund its development of monoclonal antibodies for serious infectious diseases, including its Phase II candidate ASN100 for the prevention of Staphylococcus aureus pneumonia in high-risk mechanically ventilated hospital patients in the intensive care unit (ICU). Preclinical programs target multi-drug resistant gram-negative infections and respiratory syncytial virus (RSV) as well as a program in S. aureus sepsis, which affects infants in developing countries, with funding and support from the Bill & Melinda Gates Foundation. (Also see "Finance Watch: OncoMed Cuts Costs To Conserve Capital While Public, Private Peers Raise Cash" - Scrip, 1 May, 2017.)
• InflaRx GMBH wasted no time in filing for an IPO after closing its $55m Series D round earlier this month to begin a Phase IIb program for IFX-1, a monoclonal antibody targeting complement factor C5a, in the treatment of chronic inflammatory and autoimmune indications. (Also see "Finance Watch: J&J Notes JLabs Incubators' Success Stories To Date" - Scrip, 13 Oct, 2017.) The company said in an Oct. 30 SEC filing that it may sell up to 6.67m shares for $14 to $16 each to gross more than $106m.
• Crestwood, Ky.-based Apellis Pharmaceuticals Inc. proposed terms for its forthcoming IPO in an Oct. 30 SEC filing. The company could raise up to $160.7m from the sale of 10.7m shares priced at $13 to $15 each. Apellis plans to initiate Phase III trials in 2018 for APL-2 in the treatment of age-related macular degeneration.
• Spero Therapeutics LLC could go public any day now after proposing offering terms on Oct. 23 seeking up to $80m before overallotments from the sale of 5m shares at $14 to $16 each. The Cambridge, Mass-based antibiotic developer closed a $51.7m Series C round in March and also received a grant from the government-backed antibiotic accelerator CARB-X this year.
• Allena Pharmaceuticals Inc. in Newton, Mass. also proposed IPO terms on Oct. 23 with the sale of 5.33m shares for $14 to $16 each for up to $85.33m in gross proceeds, before the sale of overallotments. The company is developing oral enzyme therapeutics for orphan metabolic diseases, including ALLN-177 for hyperoxaluria, for which Allena will begin the first of two Phase III trials in the first quarter of 2018.
• Outside of the US, Melbourne, Australia's Telix Pharmaceuticals Ltd. said on Oct. 24 that it has initiated an IPO in its home country to raise A$50m ($38.4m) via the sale of 77m shares priced at A$0.65 each. The company is running clinical programs for targeted radiopharmaceuticals in the treatment of renal, prostate and brain cancers. Telix launched earlier this year and announced a pair of acquired assets. (Also see "Start-Up Quarterly Statistics: Early Funding Declined, But Deal Dollars Flowed" - Scrip, 3 May, 2017.) It acquired rights to a third program in July. (Also see "Deal Watch: Valeant Continues Divestment Spree By Selling Obagi At A Loss" - Scrip, 25 Jul, 2017.)
• In Denmark, the local biopharma firm Orphazyme AS announced on Oct. 24 that it intends to launch an IPO on the Nasdaq Copenhagen that will raise up to DKK600m ($93.8m). The Danish biopharma firm, which counts Novo AS among its investors and has 28 employees, was founded in 2009 to pursue therapeutics targeting heat shock proteins and it is focused on the treatment of rare diseases. Orphazyme's lead drug candidate arimoclomol is in development for two neuromuscular diseases, sporadic inclusion body myositis and amyotrophic lateral sclerosis, and the lysosomal storage diseases Niemann Pick type C and Gaucher disease. The company closed a €14m ($14.8m) private funding round in March. (Also see "Venture Funding Deals: Cell Medica Raises $73.2m, Tango Dances In With $55m" - Scrip, 16 May, 2017.)

Chi-Med Closes Large Offering

Hutchison China MediTech Ltd. (Chi-Med) capitalized on its rising valuation after multiple positive clinical trial updates this year with an offering of 11.4m American Depository Shares (ADSs) priced at $26.50. The follow-on offering, which closed on Oct. 27, grossed $301.3m that will be used for general corporate purposes. Each ADS gives investors half of an ordinary share in the London-based company.

Chi-Med went public in the US at $13.50 in March 2016. (Also see "IPO Update: Investors Chase Modest Immuno-Oncology Offerings" - Scrip, 25 Mar, 2016.) The company and its partner AstraZeneca PLC recently revealed data for the c-MET inhibitor savolitinib in treatment-resistant lung cancer. (Also see "Chi-Med's Savolitinib: Overcoming Treatment Resistance in NSCLC" - Scrip, 17 Oct, 2017.) Chi-Med also reported earlier this year that its VEGF inhibitor fruquintinib has shown positive results in a Phase III colorectal cancer study. (Also see "Chi-Med Roll Continues With Positive Fruquintinib Phase III Data" - Scrip, 3 Mar, 2017.)

Other recent public company financings include:

• Ignyta Inc. grossed $160m from the sale of 10m shares, excluding overallotments, priced at $16 each in an offering on Oct. 19. The San Diego-based company launched the stock sale two days after reporting positive interim Phase II results for its TRK inhibitor entrectinib in certain lung cancer patients, sending its stock up more than 13%. Ignyta said it will seek US FDA approval based on data from the STARTRK-2 trial. (Also see "Ignyta's Entrectinib Data Sets Prospects Alight" - Scrip, 19 Oct, 2017.)
• Immune Design Corp. of Seattle, Wash. and South San Francisco grossed $80m from the sale of 19.5m shares priced at $4.10 each, before overallotments, on Oct. 24. The cash will fund a Phase III clinical trial for the cancer vaccine CMB305 in synovial sarcoma and development of CA21, including the filing of an investigational new drug (IND) application with the FDA. (Also see "Pipeline Watch: Phase III Readouts For Cabozantinib, Topical Glycopyrronium" - Scrip, 23 Oct, 2017.)
• Laval, Quebec-based Prometic Life Sciences Inc. said on Oct. 23 that it signed a binding letter of intent with Structured Alpha LP (SALP), an affiliate of Thomvest Asset Management Inc., to secure an $80m line of credit at an 8.5% interest rate. The Canadian company said the multi-tranche credit facility gives it the flexibility to fund its operations while awaiting revenue from Ryplazim (plasminogen) and seeking ways to monetize its various assets. SALP will receive warrants for up to 44m Prometic shares, received in blocks of warrants as the company draws cash from the credit facility. The US FDA has accepted a biologic license application (BLA) seeking approval of Ryplazim, the company's lead plasma-derived therapeutic, for the treatment of hypoplasminogenemia and set an April 2018 user fee date. (Also see "Pipeline Watch: Phase III Starts With Fitusiran In Hemophilia, Zoliflodacin In Gonorrhea, Opdivo Combo In RCC" - Scrip, 14 Jul, 2017.)
• VBI Vaccines Inc. in Cambridge, Mass. said on Oct. 30 that it closed a public offering of 16.1m shares at $3.05 each before overallotments for $49.1m in gross proceeds and a concurrent registered direct offering of 7.5m shares at $3.05, which grossed $22.8m. The $71.9m in total proceeds will fund the company's pipeline of infectious disease and oncology vaccine, including a Phase III study for Sci-B-Vac in the US, Europe and Canada; the hepatitis B vaccine is approved in Israel and 14 other countries. Other vaccines are in early clinical development for glioblastoma multiforme and congenital cytomegalovirus. (Also see "New Anti-CMV Therapies Post-Transplant: Merck & Co Leads The Pack" - Scrip, 2 Mar, 2017.)
• Barely a week after publishing positive Phase III results for M207 – a dermal patch delivering zolmitriptan – in the acute treatment of migraine headaches, Fremont, Calif.-based Zosano Pharma Corp. revealed a stock purchase agreement on Oct. 20 under which Lincoln Park Capital Fund LLC will buy up to $35m worth of the company's shares during a 30-month period. The proceeds will fund a long-term safety study for the product. (Also see "Pipeline Watch: Topline Phase III Results For Tenapanor, Abemaciclib" - Scrip, 13 Oct, 2017.)
• Corbus Pharmaceuticals Holdings Inc. of Norwood, Mass. grossed $32.5m before overallotments from the sale of 4.65m shares at $7 each on Oct. 24. The company will use the money for continued preclinical through Phase III development of anabasum, an endocannabinoid-mimetic drug, in rare inflammatory and fibrotic diseases, including systemic sclerosis and cystic fibrosis. (Also see "Corbus Cystic Fibrosis Data May Justify Longer, Larger Study" - Scrip, 31 Mar, 2017.)
• The Alameda, Calif.-based regenerative medicine firm BioTime Inc. closed an offering of more than 9.6m shares priced at $2.60 each on Oct. 17 for gross proceeds of $28.8m, which will be used for general corporate purposes, including clinical trials. The frequent creator of new companies spun out AgeX Therapeutics Inc. earlier this year. (Also see "Venture Funding Deals: Gene Editing Attracts Big Investors, Roivant Sets Financing Record" - Scrip, 14 Sep, 2017.)
• Syndax Pharmaceuticals Inc., which raised roughly $50m in a public offering only about five months ago, said on Oct. 17 that it will gross about $25m from a registered direct offering of more than 2m shares priced at $12.37 each and purchased by Biotechnology Value Fund LP. (Also see "Finance Watch: Bicycle Spins Toward Clinic With $52m Round; Stock Spikes Spur Offerings" - Scrip, 1 Jun, 2017.) The Waltham, Mass.-based cancer drug developer has expanded its pipeline beyond entinostat and SNDX-6352 since its last offering by licensing preclinical small molecules from Allergan PLC, also announced on Oct. 17, which Allergan acquired in its 2016 purchase of Vitae Pharmaceuticals Inc. (Also see "Deal Watch: Syndax Gets Former Vitae Leukemia Program From Allergan" - Scrip, 20 Oct, 2017.)
• The San Diego, Calif.-headquartered anti-infectives specialist Cidara Therapeutics Inc. priced 3.36m shares sold in a private placement at $6 each on Oct. 19 for $20m in gross proceeds. The syndicate buying the shares was comprised of new and existing investors, including Great Point Partners LLC, BB Biotech AG, Prosight Capital, Broadfin Capital LLC and other institutional investors. CEO Jeff Stein, who previously ran Trius Therapeutics Inc. before it was acquired by Cubist Pharmaceuticals Inc. (which was then bought by Merck & Co. Inc.), is an advocate for better incentives for anti-infective therapies as head of the Antimicrobial Working Group. (Also see "Better Incentives Needed For Worsening Fungal Infection Threat" - Scrip, 28 Jun, 2017.)

Accelerator Cydan Raises $34m To Back More Companies

The orphan drug accelerator Cydan raised $34m to fund the formation and launch of new biopharma companies with therapies to treat rare genetic diseases. A total of $34m in fresh venture capital has been committed to Cambridge, Mass.-based Cydan by new investor Longitude Capital and prior backers, including New Enterprise Associates, which led the round with additional participation from Pfizer Venture Investments, Alexandria Venture Investments and Lundbeckfond Ventures.

Cydan sources company assets from academia, government, biotech and pharma then de-risks the drug candidates through preclinical development, starting new companies backed by its own investors to run human proof-of-concept studies.

Prior launches by the accelerator include Imara Inc. with a drug licensed from H. Lundbeck AS to treat sickle cell anemia. (Also see "Pharma VC-Backed Incubator Cydan Launches Imara With $31.5m" - Scrip, 14 Apr, 2016.) Imara has completed a Phase I study in healthy volunteers and will initiate a Phase II clinical trial in sickle cell disease before the end of 2017.

Cydan's first launch was Vtesse Inc., which was developing a treatment for Niemann-Pick disease type C when it was acquired by Sucampo Pharmaceuticals Inc. for $200m up front in April. (Also see "Sucampo Looks To Add Heft With Vtesse Acquisition" - Scrip, 3 Apr, 2017.)

Two of the year's biggest private financings occurred in October, including a $200m private placement that Lausanne, Switzerland-based ADC Therapeutics SARL revealed on Oct. 23. (Also see "ADC Therapeutics Raises $105m To Reach Pivotal Studies" - Scrip, 18 Oct, 2016.) Also, the infectious disease-focused start-up Vir Biotechnology Inc. led by ex-Biogen CEO George Scangos disclosed that it has raised more than $500m since its January debut. (Also see "$500m And Counting: Vir Puts Big Money To Work In Infectious Diseases" - Scrip, 19 Oct, 2017.) Other recent significant private financings include:

• Menlo Park, Calif.-based Forty Seven Inc., which is named for the CD47 receptor targeted by its lead immuno-oncology candidate Hu5F9-G4, said on Oct. 17 that it closed a $75m Series B venture capital round. The company closed a $75m Series A round a year and a half ago to commercialize technology spun out of Stanford University. (Also see "Forty Seven Raises $75 Million For Possible 'Universal' Cancer Therapy" - Scrip, 3 Mar, 2016.) Forty Seven has five ongoing clinical trials, including Phase Ib trials for its lead monoclonal antibody candidate as a monotherapy and Phase Ib/II testing Hu5F9-G4 in combination regimens in solid tumors. The company's new funding will expand the current studies and fund new studies combining the therapy with T-cell checkpoint inhibitors. New investor Wellington Management Co. LLP led the Series B with participation from prior investors Clarus, Lightspeed Ventures Partners, Sutter Hill Ventures and GV (formerly Google Ventures).
• Y-mAbs Therapeutics Inc. closed a $50m private placement with HBM Healthcare Investments and the New York-based immunotherapy developer's existing shareholders; the company raised $12m in equity in January. Y-mAbs CEO Claus Moller said in an Oct. 24 statement that the money will finance "the final steps of the regulatory pathway towards approval" for lead product candidates burtomab, a Phase II antibody that targets B7-H3, and naxitamab, another Phase II antibody that targets GD2, in pediatric cancers. The FDA granted a breakthrough therapy designation for burtomab in neuroblastoma in June. (Also see "Keeping Track: First Gliomas Imaging Agent Wins Approval; Amgen Hopes New Repatha Data Boosts Prospects" - Pink Sheet, 9 Jun, 2017.)
• Kymera Therapeutics LLC of Cambridge, Mass. revealed a $30m Series A round to fund its targeted protein degradation platform, which the company will use to develop small molecules that harness the body's ubiquitin-proteasome system to knock down disease-causing proteins. The technology enables the identification of target protein and E3 ubiquitin ligase pairs, which may accelerate drug discovery and development in the protein degradation field. Kymera's initial focus will be oncology, immuno-oncology, autoimmune and inflammatory diseases and the company will nominate its first clinical candidate in 2018, but also will engage in drug discovery and development with partners. Atlas Venture co-founded, provided seed funding for and incubated Kymera and led the company's Series A in which Lilly Ventures and Amgen Ventures also invested.
• South San Francisco-based Blade Therapeutics Inc. triggered the funding of the final tranche of its $45m Series B, which initially closed in June 2016, by selecting its first clinical drug candidate. (Also see "VC Roundup: Annexon, Mersana Benefit As Investors Favor Private Over Public Biotechs" - Scrip, 25 Jun, 2016.) The company focused on novel anti-fibrotic diseases expects to start a clinical trial in mid-2018 for its lead drug candidate, which targets certain intracellular cysteine proteases.
• Atlas Venture, Lightstone Ventures and OrbiMed co-led a $42.5m Series A round for Gemini Therapeutics Inc. after providing the Cambridge. Mass.-based start-up's seed funding in 2016. Gemini said on Oct. 17 that it will use the money to develop precision medicines for genetically-defined dry age-related macular degeneration (AMD) and associated rare complement-mediated diseases. The multi-modality company reviewed genetic data for AMD and found multiple approaches for treating certain patients with a recombinant protein, a monoclonal antibody or a gene therapy. The technology is licensed from academic and industry sources.