Gossamer Bio, Inc. Earnings Call | Full Recording | GOSS

Company / Deal / Regulatory Updates (Gossamer Bio)

Program

• Sarah Lutinib (name transcribed in multiple ways across the call, including variations such as “Serutin,” “Sarah Ludnib,” and “Sarah Lutnib”)

FDA Pathway / NDA Plan

• Pre-NDA Type B meeting feedback
  • FDA issues were characterized as “review issues rather than filing issues.”
• Submission strategy
  • NDA basis: Proera treated as an adequate and well-controlled Phase 3 study
  • Confirmatory evidence: Tori as an independent confirmatory randomized placebo-controlled study
  • Supportive analyses: ongoing/translational analyses to support consistency and biological coherence
• Timeline
  • Planned NDA submission: September 2026
  • Potential FDA approval decision (if filed/under standard review): 3Q 2027
• Important caution
  • FDA has not accepted the NDA for filing and has not completed substantive review.

---

Reacquisition of Worldwide Rights (Capital Structure / Economics)

Transaction

• Gossamer reacquired worldwide development and commercial rights to Sarah Lutinib from Kazy/Kieazi/Kaz (spelling varies).

Economic Terms After Reacquisition (No Upfront Cash Described)

• No upfront cash payment by Gossamer to regain rights.
• Kazy pays Gossamer: $5 million shortly after signing.
• Prior arrangement (as described)
  • Shared US profits equally
  • Received royalties outside the US
• New arrangement
  • Kazy retains a capped royalty on worldwide net sales
  • Plus specified success-based milestone payments
  • Royalty:
    • Payable from commercial sales
    • Ends once the agreed cap is reached
  • Milestones:
    • Finite and contingent (replacing a “perpetual” sharing structure)

Operational Control

• Gossamer consolidates global decision-making, including:
  • Regulatory
  • Manufacturing
  • Pricing
  • Market access
  • Commercialization
  • Lifecycle development

---

Capital Structure Actions (Debt Exchange + Reverse Split)

Stockholder Vote Date

• July 14, 2026

Convertible Note Exchange (5% due 2027 → 7.5% secured due 2030)

• Exchanged about $181.1 million principal of $200 million aggregate principal of 5% convertible senior notes due 2027
• Received about $65.2 million principal of 7.5% convertible secured notes due 2030
• Also received equity securities and warrants
• Resulting debt reduction: ~$115.9 million
• Eligible holders tendering by the early deadline also received purchase warrants

Reverse Stock Split Authorization

• Authorized to support compliance with NASDAQ minimum bid price requirements and to improve the capital structure
• Split ratio/timing: to be finalized by the board action (not specified)

Liquidity (as of June 30, 2026)

• Cash, cash equivalents, and marketable securities: ~$57 million

---

Label / Indication Strategy and Expectations

NDA Indication Framing

• Intent to support a broad PH population, including prespecified analyses for:
  • Intermediate-to-high risk subgroups
  • Connective tissue disease (CTD) subgroups

Subgroup Emphasis

• Intermediate-to-high risk
  • Stated to be >80% of the Proera population
• CTD subgroup
  • Described as “unprecedented”
  • Walk distance benefit up to ~37 meters (exact endpoint wording unclear)
• Geographic results noted
  • FDA acknowledged North America and Western Europe consistency with practice of medicine over ~35 years
  • Example cited: walk distance >25 m with p-value 0.02 (North America + Western Europe)

p-value Discussion

• Per management, there was limited/no discussion at the FDA meeting around a p-value threshold
• Management referenced FDA guidance released 3 days after the meeting, suggesting that for:
  • orphan/rare diseases with high unmet need
  • an “appropriate” p-value may be p = 0.05 (as paraphrased)

---

Other Company Plans (Market / Europe / Partnerships)

Commercial Readiness

• Commercial readiness activities were paused earlier to conserve capital
• Management expects to resume launch readiness in 2H 2026
• Target launch: Aug/Sep 2027 (assuming approval)

Europe / EMA Timing

• Management expects EMA process ~1 year behind FDA, providing time to prepare outside the US

Geographies

• Intent to expand beyond the US
• EMA and other regions planned (Japan mentioned)

Partnerships

• Management stated intention to proceed as an independent company
• No stated need to add another commercial partner

PHILD Tie-In

• No direct indication that a PHILD tie-in is required (with related details below)

---

PHILD / Broader Disease Question (Risk / Confirmation Framing)

Asked: Plans for PHILD After Rights Reacquisition

• Management response presented two scenarios:

1. If PH is approved with no further confirmatory requirement
   • They would still initiate a PHILD study
2. If FDA requires additional confirmatory evidence
   • They would be happy to conduct a post-approval confirmatory study using PHILD patients
   • Confirmatory timing would depend on FDA discussions

Clarification

• PHILD is not currently presented as a linkage requirement
• It is considered within potential confirmatory pathways

---

Financial Obligations / Ongoing Payments to Kazy

Management stated no financial obligations to Kazy other than:

• Royalty on worldwide sales, and
• Success-based milestone payments (finite contingent obligations)

---

Methodology / Framework Explicitly Described (NDA Evidentiary Strategy)

NDA Evidentiary Structure

• Treat Proera as an adequate and well-controlled Phase 3 study (core efficacy/safety basis)
• Use Tori as independent confirmatory randomized placebo-controlled evidence
• Use supportive/translational analyses to demonstrate:
  • consistency
  • clinical relevance
  • biological coherence

Statistical Positioning (Qualitative)

• FDA characterized statistical significance magnitude as review issues
• Management cited FDA guidance for rare/orphan high-need contexts where p = 0.05 may be considered “appropriate”

---

Key Numbers & Timelines Pulled From Subtitles

• NDA submission: September 2026
• Potential FDA approval decision: 3Q 2027
• Kazy payment to Gossamer: $5 million after signing
• Debt exchange
  • $181.1m principal exchanged (from $200m aggregate principal)
  • To $65.2m principal of 7.5% secured convertibles due 2030
  • Debt reduction: ~$115.9m
• Cash & securities: ~$57m as of June 30, 2026
• Stockholder meeting: July 14, 2026
• Launch readiness resumption: 2H 2026
• Target launch: Aug/Sep 2027 (if approved)
• PHILD timing: dependent on FDA confirmatory needs; could start after PH approval or as confirmatory post-approval
• Efficacy example cited: walk distance up to ~37 meters (CTD subgroup)
• Geographic example: North America + Western Europe walk distance >25m at p = 0.02
• Statistical threshold reference: p = 0.05 for certain rare/orphan high unmet need contexts (cited as FDA guidance)

---

Disclosures / Disclaimers Noted

• Forward-looking statements disclaimer included by the operator/CFO:
  • Statements about planned NDA submission, regulatory timing, rights reacquisition benefits, and capital structure/runway are subject to risks and uncertainties
  • References to SEC filings and press release
• No obligation to update forward-looking statements except as required by law

---

Presenters / Sources Mentioned

• Brian Gerroto — CFO and COO (capital structure + forward-looking disclaimer)
• Fahheim Hazin — Chairman, Co-founder, and CEO
• Karen Peterson — Chief Development Officer
• Bob Smith — Commercial Officer
• FDA — referenced as providing feedback via Type B pre-NDA meeting minutes and guidance
• Operator / conference call moderator — Q&A logistics
• Questioners (analyst names)
  • Yasmine Raheem (Piper Sandler)
  • Joe Schwarz (Link Partners)
  • Ellie Merl (Barclays) — asked via “Jasmine on for Ellie” in subtitles
  • Patrick / Louis (name garbled) (HC Wainwright) — “Louis in for Patrick”
  • Paul Choy (Goldman Sachs)
  • Elaine (name garbled) (Guggenheim Securities)