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Trio of biopharmas collectively seeks $278.25M

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By Marie Powers
News Editor

The platforms are distinct but the end game is identical. Rare disease company Allena Pharmaceuticals Inc., anti-infectives developer Spero Therapeutics LLC and cancer therapy hopeful Erytech Pharma SA filed for U.S. IPOs, joining Ablynx NV, which filed days earlier, to extend the biopharma trek to the public markets into the fourth quarter.

Collectively, the trio is seeking to raise $278.25 million.

Formed by former executives and investors of Alnara Pharmaceuticals Inc. to develop nonsystemic oral protein therapeutics for metabolic and orphan diseases, Allena was launched in 2011 with a $15 million series A round. Backers included Bessemer Venture Partners, Frazier Healthcare and Third Rock Ventures. (See BioWorld Today, Nov. 16, 2011.)

In 2014, the syndicate reconvened, adding HBM Biocapital, for a $25 million series B. The following year, the company added Pharmastandard International, Fidelity and Partner Fund Management to its investor syndicate, raising a $53 million series C designed to advance lead candidate ALLN-177 to treat secondary hyperoxaluria in patients with a history of calcium oxalate kidney stones. (See BioWorld Today, Dec. 5, 2014.)

The Newton, Mass.-based company is seeking to raise up to $92 million, including an overallotment option, in the IPO and will seek to list on Nasdaq as ALNA. Credit Suisse, Jefferies and Cowen and Co. are joint bookrunners on the deal, which was not priced.

Allena's development program for ALLN-177 so far has included a phase I trial that enrolled 33 healthy volunteers and three phase II trials that enrolled a combined 113 participants with secondary hyperoxaluria. ALLN-177 is a crystalline formulation of the enzyme oxalate decarboxylase, designed to degrade oxalate within the gastrointestinal tract.

During the third phase II study, ALLN-177 reduced 24-hour urinary oxalate excretion compared to placebo, but the magnitude of change did not reach statistical significance for the primary endpoint – reduction in urinary oxalate excretion from baseline to week four of the trial. However, data from prespecified secondary endpoints and post-hoc analyses in the prespecified subgroup of patients with enteric hyperoxaluria, which included 27 percent of the overall population and 34 percent of the active treatment population, showed greater reductions in urinary oxalate excretion in the treatment arm compared to placebo. Time-weighted average 24-hour urinary oxalate excretion over the four weeks of the trial, a prespecified secondary endpoint, also achieved greater reductions in urinary oxalate excretion compared to placebo in both the overall population and the subgroup of patients with enteric hyperoxaluria.

During the company's open-label phase II trial in secondary hyperoxaluria, treatment with ALLN-177 resulted in greater reductions in urinary oxalate excretion in the enteric hyperoxaluria patient subgroup, which represented 31 percent of the overall patient population.

ALLN-177 was well-tolerated during the phase II program, with no drug-related serious or severe adverse events, according to the company, which is in discussions with the FDA to finalize design of a planned pivotal phase III program for ALLN-177 in adults with enteric hyperoxaluria. Allena expects to execute two trials evaluating efficacy and safety, with the first set to enroll participants in the first quarter of 2018.

The FDA and EMA granted orphan drug designations to ALLN-177 to treat primary hyperoxaluria, and the FDA added the orphan designation to pediatric hyperoxaluria.

In its filing, Allena reported $38 million in cash and equivalents and 68.8 million outstanding common shares as of June 30.

Spero padding coffers to address MDR pathogens

Formed in 2013, Atlas Venture-backed Spero snagged partner Roche Holding AG and a $3 million series A a year later. The round included investment from Atlas, SR One and Partners Innovation Fund. The alliance with Roche, of Basel, Switzerland, included R&D funding for Cambridge, Mass.-based Spero and an option to acquire the lead program at the IND application phase. (See BioWorld Today, April 10, 2014.)

Last year, Spero landed $30 million in a series B preferred funding that included Atlas, SR One, Partners Innovation, MRL Ventures, Lundbeckfond Ventures and the Kraft Group. Earlier this year, the company added $51.7 million in a series C preferred financing led by new investor GV (formerly Google Ventures) with participation from additional new investors RA Capital Management and Rock Springs Capital and its existing syndicate. (See BioWorld Today, March 9, 2017.)

Spero is seeking to raise $86.25 million, including an overallotment option, and plans to list on Nasdaq under the symbol SPRO. BofA Merrill Lynch, Cowen and Co., Stifel Nicolaus & Co. and Oppenheimer & Co. are joint bookrunners on the deal, which was not priced.

One of a new generation of biopharmas seeking pioneering approaches to address the growing threat of antibiotic resistance, Spero has assembled a diverse group of assets designed to provide multiple shots on goal, including approaches to infiltrate bacteria and allow existing anti-infectives to gain access to pathogens and to blunt the virulence of bacteria.

Lead candidate SPR-994 is an oral formulation of tebipenem pivoxil designed as the first broad-spectrum oral carbapenem-class antibiotic to treat adults with multidrug-resistant (MDR) gram-negative infections, with the goal of preventing hospitalizations for serious infections and enabling earlier treatment of patients following hospitalization. The initial target is complicated urinary tract infections, or cUTIs. Based on pre-IND guidance from the FDA, Spero will seek to move directly into a pivotal phase III trial predicated on favorable results from a phase I study that's expected to open enrollment in Australia in the fourth quarter, with top-line results expected in mid-2018.

The company also has a platform technology known as Potentiator to develop drugs that expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against gram-negative bacteria. The lead candidates generated from that platform include two intravenous agents, SPR-741 and SPR-206, addressing MDR gram-negative infections in the hospital setting. In addition, Spero is developing SPR-720, an oral antibiotic designed to treat pulmonary nontuberculous mycobacterial infections.

Proceeds from the IPO are expected to fund the phase I and III trials of SPR-994 in cUTI and to fund preclinical, IND-enabling and clinical studies of several Potentiator candidates.

Spero reported $36.3 million in cash and equivalents as of June 30 and 51 million outstanding common shares as of Aug. 31.

Erytech Nasdaq bid to join its Euronext Paris listing

The veteran of the trio, Lyon, France-based Erytech filed its F-1 with the SEC in a bid raise up to $100 million in the form of American depositary shares in its first U.S. placement, as ERYP, on Nasdaq. The company also is listed on the Euronext Paris as ERYP, where it completed its IPO in 2013 to raise €16.7 million (US$21.7 million). (See BioWorld Today, May 14, 2013.)

The company's market cap now is estimated at €284 million.

In 2014, Erytech had a decisive phase III win with Graspa (eryaspase), its encapsulated formulation of L-asparaginase, to prevent allergic reactions and the generation of neutralizing antibodies while keeping the enzyme in circulation and active for longer periods in treating acute lymphoblastic leukemia (ALL).

In the first arm of the trial, only two of 26 patients known to be allergic to standard L-asparaginase and treated with Graspa exhibited allergic reactions, which were mild and manageable. In the second arm, patients who had not shown allergic response during first-line treatment for ALL were randomized to Graspa or standard L-asparaginase. In all, 43 percent of those who received the standard enzyme suffered an allergic response while no one in the Graspa-treated group had an allergic reaction. (See BioWorld Today, Oct. 2, 2014.)

In September 2015, Erytech submitted its Graspa filing in the ALL indication to the EMA, but the Committee for Medicinal Products for Human Use came back with a request for more immunogenicity and pharmacodynamics information and asked for comparability studies between Graspa administered in trials, which used native L-asparaginase, and an updated version using a recently approved recombinant form of the enzyme. Erytech subsequently withdrew the application in November 2016 but indicated in its F-1 that it is on track to refile in ALL by month-end.

Earlier this year, Erytech also posted positive phase IIb results for Graspa to treat pancreatic cancer, positioning the company to pull together a €70.4 million placement to finance preparations for a phase III program in the indication, for which it holds global commercialization rights. In its filing, the company indicated plans to initiate a pivotal phase III trial in the U.S. and Europe during the third quarter of 2018. (See BioWorld Today, April 17, 2017.)

Erytech was founded in 2004. In its F-1, the company reported cash and equivalents of €88.55 million as of June 30. Jefferies, Cowen and Co. and Oddo et Cie are joint bookrunners on the U.S. offering, which was not priced.

In its third-quarter report on the U.S. IPO market, Renaissance Capital cited a slowing in the number of completed offerings, calculating that 29 IPOs during the quarter that raised $4.1 billion represented a 28 percent decline in proceeds from the same period in 2016. Biopharma IPOs helped to support total deal flow in the period, however. According to an analysis by BioWorld, 10 companies completed their IPOs in the U.S. in the third quarter, collectively raising just over $1 billion. (See related story in this issue.)