The Federal Trade Commission does not usually feature prominently in a biotech CEO’s business plan. For Jason Coloma, it very nearly became the reason his company didn’t have one. Maze Therapeutics, the South San Francisco company he has led since 2019, had signed a co-development deal with Sanofi for its lead Pompe disease program — and then watched the FTC dismantle it on antitrust grounds. Sanofi backed away. Maze, burning cash as a private company with a Phase 2 asset and no path forward, had to scramble.

“We ended up doing a better deal than the one we signed with Sanofi, which is even a little bit more remarkable,” Coloma said, speaking on The Long Run with host Luke Timmerman in an episode released in August 2026. The new partnership, with Japan’s Shionogi, came together in about six months and delivered superior economics. The near-death experience became a management doctrine. “I like this plan, but how do you think about a plan B? How do we create different options so that we’re not stuck in that period again that gave us so much uncertainty?”

That question — how to build contingency into every strategic decision — runs through Coloma’s entire approach to drug development, and it explains how Maze has turned one of biotech’s least fashionable therapeutic areas into a competitive field now crowded with Vertex and AstraZeneca.

A Career Built at Biotech’s Crossroads

Coloma’s biography reads like a tour of every major institution in the industry, and each stop deposited a skill he later used at Maze. His parents immigrated from the Philippines in the 1960s — his mother a nurse who arrived with, as he put it, “20 bucks in your pocket and the clothes in your suitcase,” his father serving in the Air Force. A high-school counselor steered him toward the University of San Francisco on scholarship, where the Jesuits instilled what he calls a framework of academic rigor and “a little bit of the more rebellious group within the Catholic Church.” The formative question — “how do I make the biggest impact to human health but not being a medical doctor?” — came during graduate work at Berkeley’s School of Public Health.

The industry answer took him first to Cytokinetics in the late 1990s, where his hiring manager was Jeff Feiner, now CEO of Septerna and later Coloma’s co-founder on the concept that became Maze. After an MBA at Dartmouth Tuck — he needed the business vocabulary to bridge science and dealmaking — came Genentech, where the 2009 Roche acquisition created an unusual cross-cultural experiment: Californians in blue jeans arriving in Basel, where “you would see Swiss-German folks trying to wear jeans — but they would be ironed.” At Roche headquarters, working under Sophie Konorski and Dan O’Day, Coloma helped architect the personalized healthcare strategy that produced the Foundation Medicine and Flatiron Health acquisitions — his first serious exposure to the idea that data, not just chemistry, could drive drug development.

Then came the apprenticeship that made the CEO. “It was a little bit of a safer environment to learn entrepreneurship, to be honest, than just going straight into the company,” Coloma said of his venture partner stint at Third Rock Ventures, where partner Alexis Borisy had recruited him — “in stereotypical fashion” — over lunch at the Rosewood Hotel on Sandhill Road. “There’s no real job board for venture. It becomes a little bit more organic, sort of relationships and individuals.”

Third Rock’s model was distinctive: “They form the ideas, form the companies as venture capitalists, but then we run those companies for a while and then bring in the management team.” It was, in Coloma’s description, “kind of like a postdoc in entrepreneurship.” He worked on Celsius Therapeutics with Aviv Regev, on the liquid biopsy company Thrive (later acquired by Exact Sciences, which itself was acquired by Abbott), and with Daphne Koller at in-Silico Medicine. Then Charles Homsey, fresh off the Myocardia board, pitched him on founding a company that would become Maze.

Genetics as the Ultimate De-Risking Tool

The founding question was deceptively simple. BridgeBio, co-founded by Homsey with Neil Kumar, had shown that genetics could crack monogenic diseases — conditions driven by a single gene. Could the same logic work for complex diseases with massive patient populations?

The tools had just arrived: UK Biobank, FinGen, and other large-scale datasets pairing genetic information with decades of clinical records, plus emerging single-cell genomics. The idea was to take a vast, undifferentiated condition like chronic kidney disease — 37 million patients in the US alone — and break it into genetically defined subpopulations with distinct biology, then drug the drivers of those subpopulations.

The APOL1 story became proof of concept. The risk variants in the APOL1 gene, Coloma explained, are “evolutionarily conserved to protect people from West Africa from this horrible thing, African sleeping sickness. The problem is if you live long enough, people ended up developing kidney disease. It’s a little like sickle cell and malaria” — protective in one context, pathogenic in another, with a disproportionate impact on the Black community. In biobank data, Maze found individuals who carried two copies of the risk variant and should have developed disease but did not; those people carried a different, protective variant. The therapeutic logic followed directly: if a small molecule could mimic that protective effect, it might prevent disease progression entirely.

When Coloma took over as CEO in 2019 — about a year after founding, with roughly 20 to 25 employees and a founding round Coloma confirms at approximately $190 million — he narrowed the company’s charter sharply. Kidney disease became the sole therapeutic area. Oral small molecules became the sole modality. The reasoning was explicit risk management: “You don’t want to compound novel biology with novel modality.”

ProgramDisease / TargetStatus (August 2026)APOL1 small moleculeAPOL1 kidney diseasePhase 2; readouts late 2026 / early 2027SLC6A19 inhibitorKidney diseasePhase 2Pompe small molecule (GYS1)Pompe diseaseLicensed to Shionogi
The Deal the Government Killed — and the One That Replaced It

The Pompe program was then Maze’s lead asset — which made the decision to partner it away deeply contrarian. Pompe is a rare lysosomal storage disease where Sanofi dominates with an injectable enzyme-replacement therapy. Sanofi had tried and failed to drug the small-molecule target internally; Maze solved the chemistry. That made Sanofi the obvious partner.

“Usually boards are like, what are you doing? You want to partner the lead program?” Coloma recalled. His argument was strategic: monetize Pompe to fund the kidney-focused pipeline the company actually wanted to build. The board agreed, the deal was signed, and then the FTC stepped in on antitrust grounds, arguing the partnership would be anti-competitive, and Sanofi backed down.

“It was horrible. It was a pretty dark time, trying to figure out… it was difficult for things that we couldn’t really control, which was more a political topic.” The timing was brutal: capital was scarce, the company was private and burning cash, and the lead program was in regulatory limbo.

The recovery taught the lesson Coloma now applies everywhere. Maze’s head of business development had quietly maintained a contingency relationship with a different potential partner. Within roughly six months, Shionogi signed on — on better terms than the Sanofi deal. The company that survived the FTC’s intervention was not the same company that had signed the original deal.

Going Public When the Window Was Shut

The same resilience carried Maze through its public debut. “Probably of the record, like no one was going public the year before,” Coloma said of the pre-IPO environment. Venture investors needed an exit, and Maze needed capital to fund two Phase 2 kidney programs. So the company went anyway.

The process was grueling, but Coloma frames it as the natural next step for a team that had already absorbed the FTC shock: “We were battle-tested and ready to go public.” The deeper point is that focus was a survival tool. By keeping the company small, single-modality, and single-therapeutic-area through several difficult capital-raising periods, Maze made its burn rate survivable long enough for the IPO window to crack open. The better economics of the Shionogi deal gave it credibility with public investors — evidence that the assets, not just the narrative, could command real value.

The Kidney Disease Revolution

Coloma’s decision to bet the company on kidney disease was directly contrary to explicit investor instruction. When he surveyed therapeutic areas after taking over, one prominent investor told him: “Oh, whatever you do, don’t do kidney.” The field had gone nearly a decade without a new drug approval. Trials were long, endpoints were ambiguous, and regulators were perceived as unwilling to engage.

That has changed, and Coloma describes the transformation as a self-reinforcing flywheel: large-scale human genetics provides credible targets; the FDA signals openness to faster, surrogate endpoints; first movers prove value can be built and captured; capital follows; more companies enter; more data accumulates; regulatory clarity deepens further.

The clinical need is stark. APOL1 kidney disease has no approved therapies. Patients progress toward what Coloma calls “crashing into dialysis,” and once on dialysis, outcomes are poor and the daily burden is severe — treatment “a couple days a week” that leaves patients wiped out and depends on family caregivers. Current standard of care is exhausted fast; Coloma quoted nephrologists saying “after I use an SGLT2, that’s it… that’s all I have.” A disease-modifying therapy that delays or prevents end-stage renal disease means patients kept off dialysis “just live longer, healthier lives.”

The regulatory breakthrough came from the FDA’s cardio-renal division — Coloma credits its head, Aliza Thompson — plus academic working groups like Parasol at the University of Michigan and advocacy groups including NefCure and the Kidney Health Initiative. The watershed precedent was Travere’s recent approval in FSGS, a rare kidney disease, supported substantially by proteinuria reduction — an endpoint that would have been unthinkable a decade ago, validated by Parasol’s engagement with the agency. Parasol has now taken on APOL1 kidney disease as its next analysis, with publication expected in 2026. That analysis could define the regulatory bar for the entire competitive field.

PlayerAPOL1 RoleStatus (August 2026)Maze TherapeuticsSmall molecule; homegrown chemistryPhase 2; readouts late 2026 / early 2027Vertex PharmaceuticalsAPOL1 programPreparing to engage FDAAstraZenecaAPOL1 programIn developmentParasol (Univ. of Michigan)Endpoint analysisPublication expected 2026

The transformation is visible at the field’s main conference. When Maze first attended the American Society of Nephrology meeting, Coloma says, it was mostly academics and clinicians. By 2024–2025, big pharma had booths, foot traffic was up, and APOL1 content had grown on the order of “eight times ten times more publications.” He frames the competitive dynamic as cooperative: Vertex and AstraZeneca are rivals in APOL1, but every company that pushes the FDA toward a workable endpoint builds shared infrastructure for the whole field. “The more that that happens, the more capital inflow goes into the therapeutic area.”

The Long Game: BridgeBio as Blueprint

Coloma is explicit about the endgame. This is not a Phase 2 exit story. He wants to build “an enduring independent company” that develops and commercializes multiple medicines — with BridgeBio as the model. To that end he has recruited two board members with exactly that experience: Neil Kumar, BridgeBio’s founder and CEO, and another public-company CEO identified in the interview. “This time next year,” Coloma hopes, Maze will be entering a pivotal study on APOL1, advancing its other kidney programs, and using its genetics-informed discovery engine to identify targets beyond kidney disease.

The entire arc — Jesuit formation, immigrant-family adaptability, Roche data strategy, Third Rock company creation — converges on the question he posed in graduate school about making the largest possible impact on human health, with Maze as his answer.

What comes next is concrete and near. APOL1 Phase 2 readouts are due in late 2026 and early 2027. The Parasol APOL1 endpoint analysis, expected this year, will likely set the regulatory bar for the entire field. Vertex’s FDA engagement will create precedent Maze must either follow or differentiate from. Shionogi’s advancement of the Pompe small molecule will test whether the post-FTC recovery truly delivered better economics. And the trajectory of Maze’s second kidney program, the SLC6A19 inhibitor — deliberately under-described in the interview but confirmed to be in Phase 2 — will determine whether the company has more than one shot on goal. The unresolved tension is that the same government that once dismantled Maze’s lead-program deal remains a wildcard in the partnership-based strategy that lets a focused company survive — a reminder that in biotech, as Coloma has learned, contingency planning is not a backup plan. It is the plan.